MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 1; KNEE PATELLA IMPLANT

Model Number	02.07.0033RP
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 july 2021: lot 175536: 130 items manufactured and released on 16-gen-2018.Expiration date: 2022-12-21 no anomalies found related to the problem.To date 126 items of the same lot have been already sold.No other similar events have been reported on this lot.Visual inspection performed by medacta r&d knee manager: revision surgery after 2 years and a half of a gmk patella resurfacing implant due to loosening.From visual inspection of the returned component , no residual cement can be seen on the explanted implant.Some scratches can be noted on the articular surface of the patella, most likely caused during the revision procedure.Reasons for improper interdigitation between implant and cement can be of various origins, most likely not implant related as suspected by the surgeon.From visual inspection there is no evidence to suspect that the event is related to a faulty device.
Event or Problem Description
Patella implant revision 2 years and 6 months after the primary due to patellar pain caused by patella mobilization (recognized through a spect ct).The surgeon suspects, that the first time he cemented the patella, he may have exceeded the cementing time and therefore it may be that the cement was not so good anymore.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1
• Common Device Name: KNEE PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12224561
• Report Number: 3005180920-2021-00607
• Device Sequence Number: 11872232
• Product Code: JWH
• UDI-Device Identifier: 07630030815737
• UDI-Public: 07630030815737
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: 02.07.0033RP
• Device Catalogue Number: 02.07.0033RP
• Device Lot Number: 175536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention