MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SM SHT SPDL W PINS 800LBF; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp (b)(4).D10: 161034 - oss rs poly fem bushings - 055390, 150493 - oss reinforced yoke - 666400, 150476 - oss poly tibial bushing - 545940, 161035 - oss rx axle - 588020, 150478 - oss poly lock pin - 024580, 161094 - oss rs 12mm ls tibial bearing - 027000, 178711 - cps/oss 5cm tpr adapt w/oss sc - 490420, 161123 - oss rs 8.5cn seg fmrl right - 922570, 178537 - cps centering sleeve - 558140, 178512 - cps nut co-cr-mo alloy - 250400, 178527 - cps transverse pin 6pk - 297810, 161022 - oss rs non-mod plate long 59 - 248150, 178554 - cps short anchor plug 12mm - 620640.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
It was reported that the patient underwent a revision approximately 4 years post implantation due to a fractured compress device.It was noted that the patient had stepped into a hole while gardening.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (hinged prosthesis right total knee arthroplasty with distal femoral resection and compress device with slight angulation of the spindle suggesting hardware fracture).A definitive root cause cannot be determined; however, it was reported the patient stepped in a hole and this could have been a contributing factor.This complaint can be confirmed based on the 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.

• Brand Name: CPS SM SHT SPDL W PINS 800LBF
• Common Device Name: PROSTHESIS, KNEE
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20560484
• Report Number: 0001825034-2024-02547
• Device Sequence Number: 18364254
• Product Code: MBF
• UDI-Device Identifier: 00880304508910
• UDI-Public: (01)00880304508910(17)300116(10)205190
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 178367
• Device Lot Number: 205190
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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