MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP MOLD STEM W/REINF 9X200; PROSTHESIS, HIP

Catalog Number	431195
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a left hip revision approximately four years post implantation due to pain.Pre-revision x-ray showed that there was an implant fracture.All components were removed and replaced.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4) 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.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: the liner, head, and stem combination radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left tha with fractured proximal femoral component.Possible cement fracture along the greater trochanter.The complaint cannot be confirmed.The root cause of the reported issue is attributed to user error, as the surgeon is only meant to implant the spacer mold for up to 180 days, as it is not designed to go beyond 180 days, as per ifu 01-50-1204.Given the provided medical records, the patient never received the second stage of the revision until 4 years later.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.

• Brand Name: HIP MOLD STEM W/REINF 9X200
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; .; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18278146
• Report Number: 0001825034-2023-02887
• Device Sequence Number: 6189778
• Product Code: MBB
• UDI-Device Identifier: 00880304521124
• UDI-Public: (01)00880304521124(17)230313(10)712120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/26/2024

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 Expiration Date: 03/13/2023
• Device Catalogue Number: 431195
• Device Lot Number: 712120
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG