MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CARPAL POLY MEDIUM- STD.; UNI2 TOTAL WRIST IMPLANT SYSTEM

Catalog Number 262300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported initially an issue with the uni2 total wrist implant system (id 262300 - carpal poly medium- std.).Additional information received on (b)(6) 2019 indicates that the prosthesis implantation was on (b)(6) 2015 for known arthrosis of the left wrist with rheumatoid arthritis.On (b)(6) 2019, there was a revision surgery in synovectomy of first extensor tendon section.The connection to the wrist shows clear synovitis upon closer inspection and removal of the synovial stratum of the polyethylene inlay on the dorsal side.Inlay sits firmly on the carpal component, no metal abrasion.

Manufacturer Narrative

Dhr: no non-conformances were identified for the lot quantity of 100 units prior to final release on april 29, 2011.Failure analysis: a portion of what appears to be the poly implant was returned; however, this segment alone did not provide any clarity to the reported event.It is unclear if the portion returned was incurred during poly replacement or was the cause of the reported inflammation.Root cause: based on the information received to date, the root cause and failure mode is undetermined.Attempts for additional information have been unsuccessful to date.If additional information becomes available, the investigation will be updated accordingly.

• Brand Name: CARPAL POLY MEDIUM- STD.
• Type of Device: UNI2 TOTAL WRIST IMPLANT SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 8750509
• MDR Text Key: 149708262
• Report Number: 1651501-2019-00024
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: K030037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 262300
• Device Lot Number: 090831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR