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

Model Number 02.12.0410FL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05.10.2021.Lot 2008570: (b)(4) items manufactured and released on 24-sep-2020 expiration date: 2025-09-09.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.

Event Description

At 6 months after primary the patient could not properly bend the knee because the patella was limiting the knee range of motion.The surgeon implanted a resurface patella, changed the inlay (implanting a new one of the same size), mobilized the knee and did a debridement to increase the knee range of motion.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM
• Type of Device: KNEE 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: 12655746
• MDR Text Key: 277115088
• Report Number: 3005180920-2021-00820
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826535
• UDI-Public: 07630030826535
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 10/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 02.12.0410FL
• Device Catalogue Number: 02.12.0410FL
• Device Lot Number: 2008570
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2020
• 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: 58 YR