K092331

Substantially Equivalent

DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;

Applicant: Encore Medical L.P.
Product code: KWA
Advisory panel: Orthopedic
Date received: 2009-08-04
Decision date: 2010-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.