GMK 3D METAL TIBIAL TRAY

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY TO ANTIBIOTIC SPACERS WITH ANTIBIOTIC CEMENT FOR THE INFECTION TO CLEAR. THE PATIENT HAD A FIRST REVISION SURGERY DUE TO INFECTION ON (B)(6) 2026, WHERE THE SURGEON REVISED THE INSERT (MDR 3005180920-2026-00704).

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 16 JULY 2026 GMK-SPHERIKA 02.12.3D05L GMK 3DMETAL TIBIAL TRAY SIZE 5L (K221850), LOT 2533415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2026. EXPIRATION DATE: 10 MARCH 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA165L GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S5L (K223548), LOT 2527024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2026. EXPIRATION DATE: 25 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.E0510FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5L - 10MM (K202022), LOT 2602505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MARCH 2026. EXPIRATION DATE: 19 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.