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

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d6a: patient underwent an initial hip arthroplasty in (b)(6) of 2022.D10: item # p0461p50, avantage 3p cup plasma ha s50 50, lot # 0001524547; item # p0461070, avan acet shell peg, lot # 0001551348; item # p0461070, avan acet shell peg, lot # 0001552947; item # p0606038, avan tap cort scr ss 4.5x38mm, lot # 0001327704; item # 802202803, femoral head 12/14 taper 28 mm diameter +3.5 mm neck length, lot # 2998968; item # p0561050, avan uhmwpe insert 50/28, lot # 0001538077.G2: report source australia.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.
Event or Problem Description
It was reported that the patient underwent a hip revision surgery approximately 2 years post implantation due to the stem impinging on the cup.The stem remained implant.Head, liner and shell replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, d6b, g3, g6, h2, h3, h6, h11.No product was returned for evaluation.Two pictures are available and showing the explanted devices.The stem remains implanted.Due to the poor quality of the pictures, a further assessment cannot be perfrormed.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.Radiographs were provided and reviewed by a radiologist.The review identified ap pelvis and single view of the left hip demonstrates a left total hip arthroplasty in place with possible asymmetric position of the femoral head within the acetabular cup which could indicate underlying polyethylene wear.Plate and screw fixation device of the acetabulum also present.No radiolucency.No acute fracture.No evidence for impingement.Based on the available information, the reported event cannot be confirmed- 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
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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20674495
• Report Number: 0009613350-2024-00536
• Device Sequence Number: 8941097
• Product Code: LZO
• UDI-Device Identifier: 00889024590991
• UDI-Public: (01)00889024590991(17)261016(10)3080673
• 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 Explanted 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): 02/14/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0106010005
• Device Lot Number: 3080673
• 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: 10/20/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• 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 Age: 69 YR
• Patient Sex: Female