MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN RADIAL BODY; TOTAL WRIST CARPUS PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This medwatch is associated with two other records: mdr #: 0001825034-2021-02773 and mdr #: 0001825034-2021-02774.

Event Description

It was reported patient underwent a revision procedure due to aseptic loosening.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: a2 the following sections were updated: a1, b4, b5, d10, g3, g6, h2, h6, h10 d10: maestro tc carpalhd 7x15mm std cat# 180363 lot# 452120 unk radial stem cat#ni lot#ni maestro tc carpalpt 9x43 8 aug cat# 180306 lot# 380980 maestro tc capitatestem 6x18mm cat# 180322 lot# 427590 variable lock screw 4.75x50mm cat# 180357 lot# 559140 visual examination of the provided pictures identified that the devices were explanted.No definitive statements can be made about the condition of the products as it is unknown whether the damage occurred intraoperatively or during explanting.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right wrist demonstrate a wrist arthroplasty with loosening of both the radial and carpal components, also with dislocation of the arthroplasty.Distal ulnar resection.Osteopenia is present with bony fragmentation noted.Erosion versus screw tract involving the base of the fifth metacarpal.Radiocarpal arthroplasty dislocation with loosening of both the radial and carpal components.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02773 0001825034 - 2021 - 02774 0001825034 - 2022 - 00078 0001825034 - 2022 - 00079 0001825034 - 2022 - 00077.

Event Description

No further event information is available at the time of this report.

• Brand Name: UNKNOWN RADIAL BODY
• Type of Device: TOTAL WRIST CARPUS PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12669650
• MDR Text Key: 277596531
• Report Number: 0001825034-2021-02776
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male