MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIVERSAL INSERTER/EXTRACTOR; INSTRUMENT, HIP

Catalog Number	31-473601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified the threads of the device are damaged.There are indentations visible to the guard and to the black handle of the device.The black handle has cracked in one location.The device has a field age of around 9 years, the frequency of usage is unknown during this period.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Based on the returned device, the complaint is confirmed.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.
Event or Problem Description
It was reported that after the surgery, the black plastic handle was found cracked.This had no impact to surgery or patient.There is no further information available at the time of this report.

• Brand Name: UNIVERSAL INSERTER/EXTRACTOR
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21558666
• Report Number: 0001825034-2025-00614
• Device Sequence Number: 4527758
• Product Code: LXH
• UDI-Device Identifier: 00887868480829
• UDI-Public: (01)00887868480829(11)150624(10)ZB150601
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 31-473601
• Device Lot Number: ZB150601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female