MAUDE Adverse Event Report: ZIMMER GMBH AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14; HIP PROSTHESIS

Catalog Number	01.06010.107
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a hip revision 2 years post implantation due to stem loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign source australia.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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).Updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6 the product involved in the reported event was not returned for investigation; however, pictures were provided and reviewed showed that the explanted stem was covered in bio debris, there appears to be some bone ingrowth towards the distal end.A review of the device manufacturing records confirmed no abnormalities or deviations.Due to insufficient product information, the compatibility of the involved products could not be verified.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.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, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• 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: 23074491
• Report Number: 0009613350-2025-00711
• Device Sequence Number: 9738418
• Product Code: LZO
• UDI-Device Identifier: 00889024591042
• UDI-Public: (01)00889024591042(17)260920(10)3080721
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 01/02/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/20/2026
• Device Catalogue Number: 01.06010.107
• Device Lot Number: 3080721
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 100 KG