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

Catalog Number	137-30001-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with rheumatoid arthritis was reported to have an infection and was brought to surgery for washout and exchange of the radial body assembly.Tests for infection, particulate and metal allergy were all negative.The surgeon reported that the implants were solidly affixed.

• Brand Name: KINEMATX
• Common Device Name: TOTAL WRIST ARTHROPLASTY
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: brian smekal ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07054 ; 9735888988
• MDR Report Key: 17995380
• Report Number: 3007289093-2023-00016
• Device Sequence Number: 6123084
• Product Code: JWJ
• UDI-Device Identifier: 00842078112014
• UDI-Public: 00842078112014
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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: 137-30001-S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Sex: Female