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

Catalog Number	0106010107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6a.Product was implanted on unknown day in (b)(6) 2018.D10.Biolox⮠option, head, l, 㸠36/+4.0, taper 8/10 item# 00877503603 lot# 2930007.G7 neutral arcomxl lnr 36mm f item# 010000741 lot# 6238073.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 approximately 6 years post implantation of a right total hip arthroplasty, the patient alleges pain in hip and severe anaphylaxis.It is unknown if revision surgery is planned.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.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.The toxicological risk assessment of the avenir müller stems and biolox® delta head has confirmed the biological safety of these implant devices for the patient.The instructions for use (ifus) of the involved products list among the contraindications: "allergy to the implanted material, above all to metal (eg.Cobalt, chromium, nickel, etc)." review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.No medical records were reviewed, but information through correspondence with the patient were received.The patient experienced burning and tingling sensations in the mouth and extremities, which worsen after exercise.These symptoms initially appeared after the closure of an atrial septal defect (asd), during which an amplatzer device (which contains nickel) was implanted and later removed due to an allergic reaction.Patient had sternal titanium plates in place and previously underwent hip replacement with titanium implants, which did not cause issues.Previously, the patient stated that she suspected her symptoms may be due to metal hypersensitivity, particularly to nickel or other metals potentially present in the sternal implant alloy.She also considered oxygen toxicity, since she was prescribed supplemental oxygen post-asd closure without re-evaluation, and some symptoms decreased upon discontinuation.However, the recurrence of symptoms after a workout has renewed her concern.Follow-ups were performed to confirm about possible patient allergy, but no information was provided.It is not possible to determine if or to what extend our hip implant contributed to the patient¿s symptoms due to the presence of multiple potential sources of metal exposure including both the sternal implant and the left-sided stryker hip implant¿each containing different alloys that could contribute to hypersensitivity or systemic reactions.Therefore, based on the available information, the reported event cannot be confirmed, and 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, LATERAL, UNCEMENTED, HA, 7, 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: 21375106
• Report Number: 0009613350-2025-00054
• Device Sequence Number: 18257500
• Product Code: LZO
• UDI-Device Identifier: 00889024479548
• UDI-Public: (01)00889024479548(17)220331(10)2899287
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 03/31/2022
• Device Catalogue Number: 0106010107
• Device Lot Number: 2899287
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2017
• 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 Sex: Female