MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0004R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 4 years and 11 months for knee instability.Femur and tibial insert revised successfully.No infection or device loosening was detected.
Additional Manufacturer Narrative
Batch review performed on 21 july 2023: lot 180366: (b)(4) items manufactured and released on 16-apr-2018.Expiration date: 2023-04-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: second revision of tka, one year after former revision surgery.The primary surgery had reportedly a defect in the position of the components: the first revision surgery tried to correct that but failed to gain stability with a primary, uncontrained implant, therefore they proceeded to a second revision shortly thereafter using a more costrained device.There are no images of the pre-revision situation, so we cannot comment on that.It seems that the second revision was caused by secondary instability because the primary implant was not adequate for a revised knee.No reason to suspect a faulty device.Additional involved implant: batch review performed on 21 july 2023 on gmk-sphere 02.12.0410fr tibial insert fixed sphere flex siye 4/10 mm r (k121416) lot.2114935 lot.2114935: (b)(4) items manufactured and released on 10-dec-2021.Expiration date: 2026-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17442900
• Report Number: 3005180920-2023-00615
• Device Sequence Number: 11440692
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 08/02/2023

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: 04/05/2023
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 180366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2018
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 94 KG