MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L; KNEE TIBIAL LINER

Model Number 02.12.0410FL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/15/2022

Event Type  Injury  

Event Description

Revision surgery performed at about 1 month and 3 weeks after the primary due to pain caused by the tibial insert not completely engaged into the tibial tray.Pre-revision x-rays confirmed the disengagement.The surgery was completed successfully by implanting a new insert.

Manufacturer Narrative

Batch review performed on 21-sep-2022: lot 2201056: (b)(4).Expiration date: 2027-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional device involved batch review performed on 21-sep-2022: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 (k090988) lot 2114767: (b)(4).Expiration date: 2027-01-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Manufacturer Narrative

Visual inspection performed by medacta r&d knee project manager: revision surgery of a gmk sphere tibial insert after one week from primary implantation due to pain.From post-op x-rays, it was discovered that the tibial insert was not engaged in the baseplate and came off.The insert looks damaged on its bottom surface, with sort of incisions of the negative shape of the peripheral contentive profile of the baseplate.This is the evidence that the insert was not engaged into the baseplate and was just leaning on top of the baseplate.Most likely the insert has never been engaged in the baseplate.From visual inspection, there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
• Type of Device: KNEE TIBIAL LINER
• 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: 15559440
• MDR Text Key: 301353825
• Report Number: 3005180920-2022-00767
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826535
• UDI-Public: 07630030826535
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.12.0410FL
• Device Catalogue Number: 02.12.0410FL
• Device Lot Number: 2201056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian