MAUDE Adverse Event Report: ZIMMER GMBH AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 5, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	0106010005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total hip arthroplasty.Approximately five (5) years post-implantation, the patient underwent revision surgery of the acetabular liner due to severe sepsis.The acetabular shell, femoral head, and femoral stem remained implanted.Five (5) months following the liner exchange, it was reported that the patient continues to experience permanent pain.Further intervention or treatment has not been reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: item # 4244, allofitâ® alloclassicâ®, shell with polar screw plug, uncemented, 50/hh, lot # 2985738.Item # unknown, unknown liner, lot # unknown.Item # 00801803214, femoral head non-skirted 12/14 taper, lot # 64156873.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, 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 that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.The complaint cannot be confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 5, 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21595269
• Report Number: 0009613350-2025-00104
• Device Sequence Number: 12967411
• Product Code: LZO
• UDI-Device Identifier: 00889024479531
• UDI-Public: (01)00889024479531(17)231130(10)2975105
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 0106010005
• Device Lot Number: 2975105
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2018
• 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: 78 YR
• Patient Sex: Female