MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. KINEMATX; TOTAL WRIST ARTHROPLASTY

Catalog Number	137-21000-S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Implant Pain (4561); Joint Impingement (4834)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was experiencing persistent pain when flexing the wrist past 30 degrees.The implant seemed to sublux and get "locked".The patient would then need to pull on his wrist to "unlock" and then can extend.This was first noticed about 3 months post-op as the patient started to use and move the wrist more.Patient had a prior distal radius non-union causing deformity.

• Brand Name: KINEMATX
• Common Device Name: TOTAL WRIST ARTHROPLASTY
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany 07054
• Manufacturer Contact: brian smekal ; 300 interpace parkway; building a, 2nd floor; parsippany 07054
• MDR Report Key: 18322739
• Report Number: 3007289093-2023-00017
• Device Sequence Number: 7026533
• Product Code: JWJ
• UDI-Device Identifier: 00842078111529
• UDI-Public: 00842078111529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 137-21000-S
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male