MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS LG 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	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: oss reinforced yoke catalog#: 150493 lot#: 66771039.Oss axle catalog#: 150480 lot#: 66675772.Oss poly lock pin catalog#: 150478 lot#: 66366561.Cps/oss 5cm tpr adapt w/oss sc catalog#: 178711 lot#: 66357290.Cps nut co-cr-mo alloy catalog#: 178512 lot#: 65964649.Oss segmental stacking adapter catalog#: 150483 lot#: 65676188.Oss poly femoral bushings catalog#: 150477 lot#: 66794531.Oss poly tibial bushing catalog#: 150476 lot#: 65779805.Oss non-mod tib plate short 75 catalog#: 161042 lot#: 459160.Cps centering sleeve 16mm catalog#: 178538 lot#: 65766788.Cps short anchor plug 14mm catalog#: 178556 lot#: 66124787.Cps transverse pin 6pk 36mm catalog#: 178528 lot#: 65985256.Oss tibial poly bearing 12mm catalog#: 150410 lot#: 66579213.Oss 3cm diaphysel segment catalog#: 150464 lot#: 012710.Oss 5cm diaphyseal segment catalog#: 150465 lot#: 012090.Oss 7cm segmental femoral lt catalog#: 150355 lot#: 66177391.Oss segmental stacking adapter catalog#: 150483 lot#: 861770.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately six weeks post-implantation due to fracture of the compress spindle.No additional patient consequences were reported.
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 product identified the complete femoral construct returned with the anchor plug fractured, not the spindle.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.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: distal left femur with fracture of the compression spindle of a long stem femoral component with distal femoral resection.Investigation results concluded that the device operated within specification and no device problem was detected.Reported event was unable to be confirmed as there was no issue with the device.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: COMPRESS LG 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: 20825818
• Report Number: 0001825034-2024-02811
• Device Sequence Number: 8955510
• Product Code: KRO
• UDI-Device Identifier: 00880304509139
• UDI-Public: (01)00880304509139(17)331004(10)65985082
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/08/2025

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: 178370
• Device Lot Number: 65985082
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown