MAUDE Adverse Event Report: ZIMMER GMBH AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	0106010006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Femoral head 12/14 taper 28 mm diameter +3.5 mm neck length item# 802202803 lot# 3172961.G2.Report source: france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient had an initial right total hip arthroplasty.The patient has had pain, discomfort, ambulation difficulties, instability, leg length discrepancy, difficulty with getting in and out of vehicle, and fear of metal toxicity since initial surgery.No treatment has been reported, and all components remain implanted.Patient will follow-up with a new surgeon approximately 9 months post-implantation.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient has been dealing with pain, discomfort, ambulation difficulties, instability, leg length discrepancy, difficulty with getting in and out of vehicle, and fear of metal toxicity.A radiographic image was provided and reviewed by a radiologist.Review of the available records identified the following: malposition of the acetabular cup and possible polyethylene wear.Based on the available information, the reported event can be confirmed the provided documentation confirms the implantation of competitor acetabular components in combination with zimmer biomet acetabular components.According to the instructions for use (ifu), this represents off-label use.If and to what extent the off-label use, acetabular cup malposition, and possible polyethylene wear are related to each other, and if and to what extent they or other patient and/or procedure related factors, contributed to the reported event, remain unknown.In addition, a review of the manufacturing process documentation confirms that potential manufacturing-related issues can be excluded.As such, based on the information available, a definitive root cause cannot be established.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: AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21548640
• Report Number: 0009613350-2025-00092
• Device Sequence Number: 12806758
• Product Code: LZO
• UDI-Device Identifier: 00889024591011
• UDI-Public: (01)00889024591011(17)280817(10)3168060
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193030
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 0106010006
• Device Lot Number: 3168060
• Was Device Available for Evaluation?: No
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 86 KG