MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2; KNEE PATELLA RESURFACING

Model Number	02.07.0034RP
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting pain due to falling and rupturing the patella tendon and damaging the collateral ligaments.The surgeon revised all implants except the patella.The surgery was completed successfully.On 18 may 2022, the patient came in reporting pain due to a patella tendon rupture and the cause is unknown.The surgeon removed the patella implant and closed the patient up without a implanting a new patella implant.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 may 2022: lot 2108181: 144 items manufactured and released on 09-sep-2021.Expiration date: 2026-08-29.No anomalies found related to the problem.To date, 139 items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2
• Common Device Name: KNEE PATELLA RESURFACING
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14733635
• Report Number: 3005180920-2022-00461
• Device Sequence Number: 2253204
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 06/17/2022

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: 08/29/2026
• Device Model Number: 02.07.0034RP
• Device Catalogue Number: 02.07.0034RP
• Device Lot Number: 2108181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female