MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEM CONST LNR 50X28; PROSTHESIS, HIP

Catalog Number	00711505028
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip revision approximately four months post implantation due to a dislocation.The liner and head were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01127.G2: 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 will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Cat #: 110010265 / osseoti multihole 54mm f visual examination of the provided pictures identified the explanted cup, liner, and head that are covered in bio-debris.From the angle of the picture it appears the head is still assembled to the liner upon explantation.No further evaluation can be made from the provided picture.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with possible fractured acetabular cup screw medially as well as dislocation superiorly of the femoral head and acetabular cup liner.The complaint is confirmed based on the evaluation of the provided x-rays.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to off label use, by cementing the tmars constrained liner into a g7 shell.Per the ifu, 87-6203-76-23 rev g, the cemented constrained liner should only be used with a well fixed trabecular metal revision system shell.Do not use trabecular metal acetabular revision system cemented constrained liner with non-compatible components.Use of non-compatible components may lead to premature wear or failure 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 additional event information to report at this time.

• Brand Name: CEM CONST LNR 50X28
• Common Device Name: PROSTHESIS, 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: 19030901
• Report Number: 0001822565-2024-01126
• Device Sequence Number: 7042037
• Product Code: KWZ
• UDI-Device Identifier: 00889024130241
• UDI-Public: (01)00889024130241(17)280820(10)65895996
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 06/24/2024

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 Catalogue Number: 00711505028
• Device Lot Number: 65895996
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female