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

Catalog Number	137-47550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw was broken.A revision surgery successfully replaced the carpal components and radial body.

• Brand Name: KINEMATX
• Common Device Name: 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: 17698173
• Report Number: 3007289093-2023-00014
• Device Sequence Number: 15140025
• Product Code: JWJ
• UDI-Device Identifier: 00842078117033
• UDI-Public: 00842078117033
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 137-47550
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/07/2023
• 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: 63 YR
• Patient Sex: Male