MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 6, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

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	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - medical devices: 56mm o.D.Size kk porous uncemented with cluster holes shell use with kk liners; item# 00875705601; lot# 62666846 biolox⮠delta, ceramic femoral head, xl, 㸠32/+7, taper 12/14; item# 00877503204; lot# 2581887 biolox⮠delta, ceramic femoral head, l, 㸠32/+3.5, taper 12/14; item# 00877503203; lot# 2734856 32mm i.D.Size kk elevated rim liner use with 56mm o.D.Size kk shell; item# 00875201232; lot# 62152055 g2 - foreign: australia.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 a reported that the patient underwent a revision surgery due to periprosthetic fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned for evaluation.There is a picture available which shows the explanted stem, ceramic head and liner.The devices are bloody and the stem has tissue on it.Based on the provided picture, no further statement can be done.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.A radiograph was provided and reviewed by a health care professional.Review of the available records identified the following: ap view of the right hip demonstrates a right total hip arthroplasty with periprosthetic fracture involving the lateral cortex of the proximal femoral diaphysis.Osteopenia.Hetero topic ossification along the greater trochanter.No surgical reports were provided.This complaint was confirmed based on the provided x-ray.Nevertheless, with the available information, 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 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, LATERAL, UNCEMENTED, HA, 6, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
• 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: 17849907
• Report Number: 0009613350-2023-00547
• Device Sequence Number: 6890373
• Product Code: LZO
• UDI-Device Identifier: 00889024591028
• UDI-Public: (01)00889024591028(17)180429(10)4020981
• 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): 10/19/2023

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.106
• Device Lot Number: 4020981
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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