MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MUELLER STEM, LATERAL, UNCEMENTED, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349); Insufficient Information (4580)
Date of Event	09/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: biolox delta head, 12/14, 36x0 catalog#: 00-8775-036-02; lot#: 3072057.Therapy date: (b)(6) 2021.The manufacturer received photographs and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that patient was revised due to implant fracture.
Additional Manufacturer Narrative
D10 concomitant devices biolox delta head, 12/14, 36x0 catalog#: 00-8775-036-02; lot#: 3072057 d10: therapy date: (b)(6) 2021.Investigation results were made available.1.Event description: it was reported that the patient underwent right total hip arthroplasty (b)(6) 2021 and had a revision surgery on (b)(6) 2021 due to a fall event, whereby the patient fractured their hip.Harm: s3 - bone fracture.Hazardous situation: patient's anatomy is exposed to excessive external forces postoperatively.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.The following sap extracts to the initial and revision procedures were provided by the sales representative: devices used during implantation.Surgery description of implantation: right avenir continuum ltc.Surgery description of revision surgery: right hip ncb pp with gt attachment on stc for periprosthetic fracture.Devices used during revision surgery.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient underwent right total hip arthroplasty (b)(6) 2021 and had a revision surgery on (b)(6) 2021 due to a fall event, whereby the patient fractured their hip.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the extent of the periprosthetic fracture as well as the condition of the components is unknown.Based on the received information, the reported event cannot be confirmed.The reported fall event has been reported as being directly correlated with the fracture of this hip.Therefore, based on the given information and the results of the investigation, this is likely to be the root cause of the reported event of periprosthetic bone fracture.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: AVENIR MUELLER STEM, LATERAL, UNCEMENTED, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• 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: 12568563
• Report Number: 0009613350-2021-00511
• Device Sequence Number: 1113192
• Product Code: LZO
• UDI-Device Identifier: 00889024590922
• UDI-Public: 00889024590922
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2021

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.101
• Device Lot Number: 2927103
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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
• 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; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female