K063414

Substantially Equivalent

MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38

Applicant: Encore Medical L.P.
Product code: KWA
Advisory panel: Orthopedic
Date received: 2006-11-13
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Special
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.