MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACETABULAR REVISION SYSTEM - CAGE, LEFT SHORT FLANGE USE WITH 56/58/60 MM SHELLS; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a failure of the bone cement that resulted in the cemented cup pulling out of the acetabular cage.The cement was the failure point of this surgery.Revision procedure has not been scheduled at this time.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00700005820 item name 58mm cup size revision shell lot # 64016660 depuy smart set ghv cement.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02469.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing for the cage.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left-sided acetabular reconstruction.Left total hip arthroplasty with loosening or malposition of an acetabular cup which is vertically oriented.Dislocation of the left femoral head which also appears to be dissociated from the femoral stem.The root cause of the reported issue is attributed to off label use, as per the product compatibility chart, acetabular reconstruction polyethylene liners/cups and metal cages/rings, the tm revision cage is only to be used with tm products and the off-label use could have contributed to the reported event.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information at the time of this report.

• Brand Name: ACETABULAR REVISION SYSTEM - CAGE, LEFT SHORT FLANGE USE WITH 56/58/60 MM SHELLS
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17738230
• Report Number: 0001822565-2023-02470
• Device Sequence Number: 17800706
• Product Code: JDI
• UDI-Device Identifier: 00889024130524
• UDI-Public: (01)00889024130524(17)240930(10)3002485
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00712405648
• Device Lot Number: 3002485
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male