MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 2, TAPER 12/14; COATED HIP FEMUR PROSTHESIS, MODULAR

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent hip prostheses implantation approximately one (1) month ago.Twenty (20) days after original surgery, patient was revised due to bone fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) g2: foreign - australia.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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are 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.

• Brand Name: AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 2, TAPER 12/14
• Common Device Name: COATED HIP FEMUR PROSTHESIS, MODULAR
• 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: 17434285
• Report Number: 0009613350-2023-00430
• Device Sequence Number: 6799377
• Product Code: LZO
• UDI-Device Identifier: 00889024590939
• UDI-Public: (01)00889024590939(17)241031(10)3008030
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/24/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.002
• Device Lot Number: 3008030
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose