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

Catalog Number	137-30002-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was removed without incident, and no visible defects were observed.A fusion plate was implanted.
Event or Problem Description
It was reported that the patient had non-specific wrist pain, and difficulty executing flexion.The patient reportedly wanted the implant removed and have a wrist fusion.

• Brand Name: KINEMATX TOTAL
• Common Device Name: WRIST ARTHROPLASTY
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: mary hoffman ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07504 ; 9735888980
• MDR Report Key: 22114599
• Report Number: 3007289093-2025-00003
• Device Sequence Number: 7062760
• Product Code: JWJ
• UDI-Device Identifier: 00842078112021
• UDI-Public: (01)00842078112021(10)229108(11)221128(17)271128
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 137-30002-S
• Device Lot Number: 229108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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 Age: 64 YR
• Patient Sex: Female