MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM R

Model Number	02.12.0514FR
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 november 2021: lot 154789: (b)(4) items manufactured and released on 02-feb-2016.Expiration date: 2021-01-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Other device involved: batch review performed on 15 november 2021.Gmk-sphere 02.07.0034rp patella resurfacing size 2(k090988)lot 180309: (b)(4) items manufactured and released on 08-may-2018.Expiration date: 2023-04-25.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported eve.
Event or Problem Description
At 1 year 5 months after the primary, the patient came in reporting pain and stiffness due to a flexion contracture.The cause of the flexion contracture is unknown.The surgeon revised the poly (14 mm to 13 mm) and also revised the patella to be more lateral.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM R
• Common Device Name: TIBIAL 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: 12951285
• Report Number: 3005180920-2021-00949
• Device Sequence Number: 1728798
• Product Code: JWH
• UDI-Device Identifier: 07630030826825
• UDI-Public: 07630030826825
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 12/07/2021

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: 01/18/2021
• Device Model Number: 02.12.0514FR
• Device Catalogue Number: 02.12.0514FR
• Device Lot Number: 154789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2016
• 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