MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL INSERT PS FIXED SIZE 4/12MM

Model Number 02.07.0412PSF

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 march 2021: lot 173732: (b)(4) items manufactured and released on 26-jul-2017.Expiration date: 2022-07-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient had a primary surgery and was implanted with competitor implants.On (b)(6) 2021, the patient had the competitor implants revised to medacta implants for reasons unknown.Presently, on (b)(6) 2021, the patient came in reporting pain due to a torn patella tendon.The cause of the torn patella tendon is unknown.The surgeon repaired the patella tendon and revised the insert p.S.12mm s4 with a insert semiconstrained 12mm s4.The surgery was completed successfully.

• Brand Name: GMK-REVISION TIBIAL INSERT PS FIXED SIZE 4/12MM
• Type of Device: 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: 11640108
• MDR Text Key: 244613951
• Report Number: 3005180920-2021-00277
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• 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: 04/09/2021

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 Expiration Date: 07/11/2022
• Device Model Number: 02.07.0412PSF
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 173732
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2017
• 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