MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MULLER STEM, STANDARD,UNCEMENTED, HA, 8, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after performing rotational movement in the left hip joint, the patient experienced a loss of strength and fell resulting in a fracture of neck area of the left hip prosthesis.Revision surgery with stem replacement and inlay replacement was performed approximately 3 years post-implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products; unknown liner; item#: unknown; lot#: unknown.Report source: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: item name#dural alpha insert neutr kk/32; item number#0100013411; lot# 2951278.Item name#femoral head +10.5x32mm dia; item number#00801803205; lot# 64069170.Item name#unknown screw; item number#unknown screw; lot#unknown.The following sections were updated: b4, b5, d9, d10, g3, g6, h2, h3, h6, h10.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The avenir müller stem with mounted metal head and a durasul alpha insert with an inserted screw for disassembly have been received for examination.The anchoring surface of the stem has bone remains on all surfaces.The stem neck is fractured separating the femoral head from the stem body.Both fracture surfaces show beach marks originating laterally and indicating a fatigue fracture.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.A single view of the left hip demonstrates incomplete evaluation of a left total hip arthroplasty.There does appear to be acute angulation at the junction of the femoral neck and femoral stem suggesting fracture.Findings suggesting fracture of a left total hip arthroplasty at the junction of the femoral neck and stem.No definite contributing factors are seen on this limited image.No signs of loosening, wear, or radiolucency.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 MULLER STEM, STANDARD,UNCEMENTED, HA, 8, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16626351
• Report Number: 0009613350-2023-00127
• Device Sequence Number: 4458136
• Product Code: LZO
• UDI-Device Identifier: 00889024591059
• UDI-Public: (01)00889024591059(17)210131(10)2836759
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 09/07/2023

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.008
• Device Lot Number: 2836759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 06/07/2023; 09/06/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/18/2023; 07/06/2023; 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2015
• 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 H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male