MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0003R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 august 2022.Lot 2101894: 54 items manufactured and released on 30-mar-2021.Expiration date: 2026-mar-14.No anomalies found related to the problem.To date, 51 items of the same lot have been sold with no similar reported event during the period of review.Additional involved implants batch review performed on 24 august 2022 on gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.2011075.Lot 2011075: 134 items manufactured and released on 11-mar-2021.Expiration date: 2026-feb-28.No anomalies found related to the problem.To date, 127 items of the same lot have been sold with one similar reported event during the period of review.Batch review performed on 24 august 2022 on gmk-sphere 02.12.0212fr tibial insert fixed sphere flex size 2/12 mm r (k121416) lot.2100080.Lot 2100080: 30 items manufactured and released on 25-mar-2021.Expiration date: 2026-mar-11.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 24 august 2022 on gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.2101550.Lot 2101550: 240 items manufactured and released on 08-apr-2021.Expiration date: 2026-mar-22.No anomalies found related to the problem.To date, 227 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in reporting pain and the cause of the pain is unknown.At about 1 month after the primary surgery, the surgeon revised all implants and the surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15409150
• Report Number: 3005180920-2022-00697
• Device Sequence Number: 15191721
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: 03/14/2026
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 2101894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2021
• 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