MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UC-PLUS SOLUTION TIBIAL INSERT 48/10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 26151

Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 03/21/2018

Event Type  Injury  

Event Description

Revision surgery performed due to aseptic loosening of the uc-plus solution insert after 5 years and 5 months.

Manufacturer Narrative

Results of investigation: a revision surgery of a uc-plus solution insert after 5 years and 5 months was reported.One uc-plus tibial insert, one tibial metal backed component and one femoral component were returned for investigation.Large amount of bone cement are observed on the femur component.Little to no bone growth is visible on the tibial component.A 15 mm x 20 mm about 2 mm deep damage is observed on the articulating surface of the pe insert.A measure of the roughness of the tibial component did not detect any deviation.No deviation from the standard manufacturing processes were observed on the corresponding production documentation.The provided information indicated that the patient had 10 previous right knee surgeries before the implantation of the complained devices.The provided revision report indicates that the implants were free of loosening, which was confirmed by the provided x-rays.It was further described that the knee arthrosis continued and the treatment was the revision to a total knee replacement.The pre-revision x-rays show an uni-condylar knee replacement with a too large tibial component that extends the medial condyle and is not aligned orthogonally with respect to the tibial axis.The femoral component is positioned towards posterior.The reported aseptic loosening was not confirmed.Whether the described implant position contributed to the reported revision remains unclear.No information was provided that indicated a mal-performance of the device.Based on the performed investigation, the root cause of the reported issue could not be determined.There is however to the best of our knowledge no indication that the device failed to match specifications at the time of manufacturing.No further actions have been initiated.

• Brand Name: UC-PLUS SOLUTION TIBIAL INSERT 48/10MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• MDR Report Key: 7376925
• MDR Text Key: 103667133
• Report Number: 9613369-2018-00018
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K982859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 26151
• Device Catalogue Number: 75006214
• Device Lot Number: 0609.13.3877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 107