MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 3; KNEE PATELLA INSERT

Model Number	02.12.0512FR
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 7 years and 5 months after the primary surgery, the patient came in reporting patella pain and the cause is unknown, but it wasn`t related to the implant.The surgeon performed a lateral release and revised the poly as a standard procedure.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12.11.2021: lot 140361: (b)(4) items manufactured and released on 25-03-2014.Expiration date: 2019-02-28 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event since 2017.
Event or Problem Description
At 7 years and 5 months after the primary surgery, the patient came in reporting patella pain and stiffness.The pain and stiffness were addressed by a soft tissue release of the lateral tissue and with a lateral patellar chamfer of the bone not covered by the offset patella button.The surgeon performed a lateral release and revised the tibial insert as a standard procedure (the same size only due to the joint was already exposed).The patella implant was not revised.
Additional Manufacturer Narrative
Batch review performed on 06.December.2021: gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 136083: (b)(4) items manufactured and released on 7-feb-2014.Expiration date: 2018-12-31 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event since 2017.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 3
• Common Device Name: KNEE PATELLA INSERT
• 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: 12916762
• Report Number: 3005180920-2021-00933
• Device Sequence Number: 12159876
• Product Code: JWH
• UDI-Device Identifier: 07630030826788
• UDI-Public: 07630030826788
• 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: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 02/28/2019
• Device Model Number: 02.12.0512FR
• Device Catalogue Number: 02.12.0512FR
• Device Lot Number: 140361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2014
• 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: Male