MAUDE Adverse Event Report: ZIMMER TMT NEXGEN TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT; PROSTHESIS, HIP

Model Number	N/A
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: concomitant devices: cat# 110010269 lot# 66175382 g7 osseoti multihole 62 mm h unk biomet stem.Unk modual cocr head 28 mm +6 neck.Unk g7 liner dm liner 44 mm.The product was evaluated through manufacturing review and medical records confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.This device was erroneously reported under an incorrect complaint file and is now being submitted under the appropriate complaint file and mfr site.See original report 3005751028-2025-00019.
Event or Problem Description
It was reported that during the patient's most recent right hip arthroplasty, the patient experienced nerve damage that has resulted in the muscle not firing and leading to an inability to walk.Nerve conduction studies have been performed and the patient was diagnosed with femoral neuropathy.The patient is planning to be admitted to an inpatient rehabilitation center for intensive rehabilitation.Attempts have been made and no further information has been provided.

• Brand Name: NEXGEN TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25000792
• Report Number: 3005751028-2026-00033
• Device Sequence Number: 21275627
• Product Code: LPH
• UDI-Device Identifier: 00889024306899
• UDI-Public: (01)00889024306899(17)270504(10)65431340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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 Model Number: N/A
• Device Catalogue Number: 00489406215
• Device Lot Number: 65431340
• 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: 04/08/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 104 KG