MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO TC CAPITATESTEM 6X18MM TOTAL WRIST CARPUS PROSTHESIS

Catalog Number 180322

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). Concomitant medical products: maestro tc carpalhd 7x15mm std cat# 180363 lot# 452120; unk radial body cat#ni lot#ni; unk radial stem cat#ni lot#ni; maestro tc carpalpt 9x43 8 aug cat# 180306 lot# 380980; variable lock screw 4. 75x50mm cat# 180357 lot# 559140. Visual examination of the provided pictures identified that the devices were explanted and confirmed part and lot numbers for the carpal component. No definitive statements can be made about the condition of the products as it is unknown whether the damage occurred intraoperatively or during explanting. Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event. 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, 0001825034-2021-02776, 0001825034-2021-02774, 0001825034-2022-00078 and 0001825034-2022-00077.

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

(b)(4). Concomitant medical products: maestro tc carpalhd 7x15mm std cat# 180363 lot# 452120; unk radial body cat#ni lot#ni; unk radial stem cat#ni lot#ni; maestro tc carpalpt 9x43 8 aug cat# 180306 lot# 380980; variable lock screw 4. 75x50mm cat# 180357 lot# 559140. Visual examination of the provided pictures identified that the devices were explanted and confirmed part and lot numbers for the carpal component. No definitive statements can be made about the condition of the products as it is unknown whether the damage occurred intraoperatively or during explanting. Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event. 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, 0001825034-2021-02776, 0001825034-2021-02774, 0001825034-2022-00078 and 0001825034-2022-00077.

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.

• Brand Name: MAESTRO TC CAPITATESTEM 6X18MM
• 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: 13311194
• MDR Text Key: 285432427
• Report Number: 0001825034-2022-00079
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 180322
• Device Lot Number: 427590
• Was Device Available for Evaluation?: No
• 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
• Date Device Manufactured: 03/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/20/2022 Patient Sequence Number: 1