MAUDE Adverse Event Report: ZIMMER GMBH AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an initial hip replacement.Subsequently, two weeks post implantation, experienced a periprosthetic fracture and revision surgery was performed.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Biolox⮠delta, ceramic femoral head, s, 㸠32/-3.5, taper 12/14 item# 00877503201 lot# 3133012.48mm o.D.Size gg porous uncemented with cluster holes shell use with gg liners item# 00875304801 lot# 65433673.32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell item# 00875200832 lot# 65310435.Uncemented single pack dome hole plug item# 00875300001 lot# 65377200.G2.Report source: spain.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 3500a will be submitted.
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 not provided.However, the implant stickers for the implantation and revision surgery were provided.Based on these stickers, the reported event can be confirmed.However, 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.
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, b5, g3, g6, h2, 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 for the implantation surgery were provided and reviewed by a healthcare professional with the following findings: the procedure was performed via a lateral approach.The patient demonstrated good range of motion (rom) intraoperatively.No complications were observed.Postoperative x-ray confirmed correct implant placement and satisfactory alignment of the femur.Medical records leading up to as well as for the revision surgery were provided and reviewed by a healthcare professional with the following findings: the patient reported pain while walking with partial weight-bearing using a walker.An x-ray showed a spiral burst fracture due to osteoporosis with femoral implant impaction, and revision surgery with a hook plate was planned.After this, revision surgery was performed using the previous incision.The uncemented stem was removed, the vancouver type b2 periprosthetic fracture was reduced with a gtr plate, screws, and bone matrix, and a new cemented femoral stem with a ceramic head was implanted.A drain was placed, and the surgery was completed without complications.Based on the available information, the reported event can be confirmed.However, the outcome of the investigation remains unchanged.A definitive root cause for the reported event 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.
Event or Problem Description
It was reported that the patient had and initial right total hip arthroplasty.Subsequently, two weeks post implantation, experienced a periprosthetic fracture to the grater trochanter and revision surgery was performed.The head and stem were exchanged for a cemented one, a hook plate and screws, bone matrix and distal centralizer.The shell and liner remained implanted.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, 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: 21114644
• Report Number: 0009613350-2025-00011
• Device Sequence Number: 15643545
• Product Code: LZO
• UDI-Device Identifier: 00889024590977
• UDI-Public: (01)00889024590977(17)270705(10)3111300
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K193030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 08/29/2025

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 Model Number: N/A
• Device Catalogue Number: 0106010004
• Device Lot Number: 3111300
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 03/27/2025; 08/29/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/28/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female