MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZSS PROXIMAL FEMORAL TISSUE ATTACHMENT KIT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687)
Date of Event	07/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was further reported that the patient underwent an initial surgery.Approximately 5 years post-op, the patient presented with left lateral hip pain and could feel the fractured implants.The patient was subsequently revised due to 2 implanted bolts fracturing.The threaded part of the bolt screws were unable to be removed and left in place as there were no proper instruments to unscrew it from the femur.In addition, the surgeon did not attempt to place a new washer and bolt screw as the chances of damaging the bolt screw thread were high and it could lead to loosening.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).G2 : foreign country: singapore.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h10; h11.Visual examination of the returned products identified signs of implantation in the form of wear lines and surface marks.The threaded portion of both implant screws was found to be fractured off.The device was submitted for further analysis.Analysis determined the presence of fatigue striations suggests the fatigue mode of failure.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with horizontal orientation of the acetabular cup.Loosened appearance of an inferior plate fixation device with associated loosened bolt along the proximal left femur laterally.Root cause was unable to be determined.Reported event was confirmed by complaint sample evaluation and review of provided radiographs.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 at time of this report.

• Brand Name: ZSS PROXIMAL FEMORAL TISSUE ATTACHMENT KIT
• Common Device Name: PROSTHESIS, KNEE
• 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: 19990964
• Report Number: 0001822565-2024-02668
• Device Sequence Number: 15194652
• Product Code: KRO
• UDI-Device Identifier: 00889024195813
• UDI-Public: (01)00889024195813(17)280131(10)63923056
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K110940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/31/2025

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 Model Number: N/A
• Device Catalogue Number: 00585003214
• Device Lot Number: 63923056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/27/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Male