MAUDE Adverse Event Report: ZIMMER GMBH TRIAL HEAD 28 M TAPER 12/14; HIP INSTRUMENT

Catalog Number	01.01559.228
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when trailing the head, the prov head wouldn't sit in the prov stem.Upon looking at the inside of the head, we realised there is a part inside it that is crooked.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4) g2: report source canada.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated:b4,b5,d2,d4,d9,g1,g3,g6,h1,h2,h4.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
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6 the product involved in the reported event was returned for investigation.Visual inspection of the returned trial head revealed multiple surface defects.Scratches were observed on the spherical articulating surface and examination of the underside identified one tab exhibiting deformation and another tab that was cracked.All tabs showed evidence of gouging and deformation consistent with repeated prior use.The device has an estimated field age of approximately 4.5 years.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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
No further information is available at the time of this report.

• Brand Name: TRIAL HEAD 28 M TAPER 12/14
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23180754
• Report Number: 0009613350-2025-00749
• Device Sequence Number: 13259826
• Product Code: JDI
• UDI-Device Identifier: 00889024283480
• UDI-Public: (01)00889024283480(11)210219(10)4504188843
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2026

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: 01.01559.228
• Device Lot Number: 4504188843
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 03/04/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 02/17/2026; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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