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

Catalog Number	137-50012-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a loose baseplate was replaced approximately 4 months post-op in a patient with poor bone quality.

• 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: 18356648
• Report Number: 3007289093-2023-00021
• Device Sequence Number: 15054793
• Product Code: JWJ
• UDI-Device Identifier: 00842078116814
• UDI-Public: 00842078116814
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K191525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/19/2023

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?: Yes
• Device Catalogue Number: 137-50012-S
• Device Lot Number: 219010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/19/2023
• 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: 52 YR
• Patient Sex: Male