MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM INSERTER; INSTRUMENT, HIP

Catalog Number	00780506101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic on the tip of the stem inserter was cracked.There was no patient injury as a result of the malfunction.There is no further information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d9;g3;h2;h3;h6 product was returned and evaluated.Visual examination of the returned product identified the blue plastic sleeve was confirmed to be fractured.The blue sleeve was still held on the tip slider component from the epoxy used during assembly.No fractured pieces were returned with the device for evaluation.The handle and all components appeared to fully actuate as intended.The blue plastic sleeve had scratches and gouges all around it.There were scratches and nicks along the main body and tip of the driver shaft.The strike plate end had multiple indentation marks.The device has an approximate field age of 9.5 years.Review of the device history record identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.Based on the returned product review, the complaint was 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.

• Brand Name: STEM INSERTER
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22002141
• Report Number: 0001822565-2025-01338
• Device Sequence Number: 9042939
• Product Code: LXH
• UDI-Device Identifier: 00889024135147
• UDI-Public: (01)00889024135147(11)151202(10)63221786
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 00780506101
• Device Lot Number: 63221786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2015
• 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: Unknown