MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HYBRID OFFSET SHELL INSERTER; PROSTHESIS, HIP

Catalog Number	00780402520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: zimmer part number: 00-8757-058-00 continuum tm shell uni 58 ll, lot number: 66495851.The reported product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that while inserting the cup, the impactor tip broke.Subsequently, the cup was removed, and a larger cup was used.No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Visual examination of the returned product identified the tip of the threaded end on the device is fractured, no fractured fragments were returned.The strike plate end has indentation marks, nicks and scratches are present across the device.No other damage was noted during visual evaluation.This device has an approximate field age of 7 years.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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 trends.
Event or Problem Description
No additional information available for the reported event.

• Brand Name: HYBRID OFFSET SHELL INSERTER
• Common Device Name: PROSTHESIS, 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: 22797927
• Report Number: 0001822565-2025-02923
• Device Sequence Number: 8314836
• Product Code: LXH
• UDI-Device Identifier: 00889024134096
• UDI-Public: (01)00889024134096(10)64051655
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 00780402520
• Device Lot Number: 64051655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2018
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Male