MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUP POSITIONER; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown shell unknown g2: foreign: canada 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
It was reported that the threads of the impactor would not hold the shell implant.No known impact or consequence to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.It was reported that no additional information is available, therefore, no further information has been provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.Review of complaint history identified no additional similar complaints for the reported positioner.However, as the lot number is unknown, an additional review could not be performed.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, d9, g3, g6, h2.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified strike plate and handle body have damage from previous uses.Indentation, nicks, and scratches are present.Threaded tip is damaged and fractured at the leading thread.Thread form does not conform to print.No broken / fractured pieces were returned with the device for evaluation.No other damage was noted.The cap and cup were not returned.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the inserter and part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.

• Brand Name: CUP POSITIONER
• Common Device Name: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; .; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21324207
• Report Number: 0001822565-2025-00284
• Device Sequence Number: 8603881
• Product Code: LXH
• UDI-Device Identifier: 00889024120136
• UDI-Public: (01)00889024120136(10)64497323
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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 Model Number: N/A
• Device Catalogue Number: 00626001800
• Device Lot Number: 64497323
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 07/16/2025; 12/29/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/16/2025; 08/12/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown