MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products ¿ hxpe liner elevated kk 32; item# 00875201232, lot# 63264393.Report source: foreign ¿ 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 total hip arthroplasty on an unspecified date, and subsequently a revision was performed due to pain.The stem was still well fixed intraoperatively, however the surgeon chose to remove and insert a cemented stem.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h3, h4, h6, h10.Visual examination of the provided pictures identified what appears to be bone on-growth and a mark on the dorsal of the stem which appears to be clean suggesting it could have been caused by fixation or during explantation.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed, but not submitted to mmi at this time as undated image would be difficult to correlate to allegation.The superimposed template obscures the image and mmi would not be able to provide a complete assessment.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 MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, 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: 16662206
• Report Number: 0009613350-2023-00144
• Device Sequence Number: 14945598
• Product Code: LZO
• UDI-Device Identifier: 00889024590953
• UDI-Public: (01)00889024590953(17)191130(10)4024332
• 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 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): 05/05/2023

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: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 0106010003
• Device Lot Number: 4024332
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose