MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. 44MM O.D. SIZE F BEARING; PROSTHESIS, HIP

Catalog Number	110031012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Neuropathy (1983); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010269 lot# 66175382 g7 osseoti multihole 62mm h.Unk biomet stem.Unk modual cocr head 28mm +6 neck.Unk g7 liner dm liner 44mm.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient had an initial right total hip arthroplasty followed by a revision five months post-operative due to three recurrent dislocations.A second revision was performed approximately 9 years due to pain and ossification.Two months post-second revision, patient underwent a dair for wound dehiscence a third revision due to recurrent dislocations.Following the revision, experienced excruciating pain due a fractured acetabular screw and underwent a fourth revision.During the procedure, the patient reports, the construct fell part in the surgeons and the gluteus muscles were damage.Subsequently, following the procedure, the right quad muscle is not firing, leading to an inability to walk.The patient is alleging that during the fourth revision, a nerve was flattened from either the fractured screw or the procedure.Nerve conduction studies have been performed and identified femoral neuropathy.All implants remain implanted at this time and then patient is planning to be admitted to an inpatient rehabilitation center for an intense rehab program.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided of the products; visual and dimensional evaluations could not be performed.Images were provided of the incision wounds, however is not relevant for the reported event.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a revision due to pain as a result of a fractured acetabular screw.The patient noted on follow-up that during the procedure the construct fell apart and the gluteus muscles were damaged.Since the procedure, the quads have not fired and patient is unable to walk and uses a wheelchair majority of the time.The patient suspects the nerve was flattened from either the fractured screw or procedure.A nerve conduction study was carried out and results shared suggests severe acute denervation changes in the vastus lateralis with early reinnervation changes.This is consistent with severe right femoral neuropathy.Patient is planning to be admitted in rehabilitation centre.No further information was provided.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 for trends.

• Brand Name: 28MM I.D. 44MM O.D. SIZE F BEARING
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23543850
• Report Number: 0001822565-2025-04112
• Device Sequence Number: 9718865
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)290503(10)66625458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110031012
• Device Lot Number: 66625458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 104 KG