MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND 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	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to implant fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
Upon review of this complaint from an investigation perspective, it is considered that the avenir maller, stem, standard, uncemented, ha, 8, taper 12/14, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 0009613350-2023-00127.
Additional Manufacturer Narrative
(b)(4).D10; unknown liner; item#: unknown; lot#: unknown.Upon review of this complaint from an investigation perspective, it is considered that the avenir muller, stem, standard, uncemented, ha, 8, taper 12/14, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 0009613350-2023-00127.

• 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 MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND 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: 16641624
• Report Number: 0009613350-2023-00118
• Device Sequence Number: 5367662
• 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
• Report Date (Section B): 05/31/2023

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?: 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: 03/08/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose