MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a left total knee arthroplasty.Subsequently, less than a week later while at physical therapy, the patient almost fell down.The patient developed increasing pain, instability with difficulty walking, and upon assessment, had a large effusion.Radiographic imaging displayed a slightly angulated far distal periprosthetic femur fracture.Approximately 9 days post implantation, the patient underwent a revision where a hematoma was evacuated, and fractures were noted to the medial and femoral condyles.All components, except for the patella, were revised without complication.
Additional Manufacturer Narrative
(b)(4).D10: 42512400414 - articular surface - 65302419; 42532006701 - tibial component - 65944994.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 further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical (g04) ¿ femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified: mildly displaced.Periprosthetic fracture of the distal femur, knee varus, loosening of the femoral implant due to the periprosthetic fracture, bone quality is osteopenic, pain increased with walking, instability, difficulty walking, effusion with no signs of infection, hematoma, revised all components but the patella.A definitive root cause cannot be determined for the bone fracture.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.Therefore, the hematoma is unrelated to 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.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17867989
• Report Number: 3007963827-2023-00265
• Device Sequence Number: 15353794
• Product Code: JWH
• UDI-Device Identifier: 00889024229150
• UDI-Public: (01)00889024229150(17)321113(10)65521850
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500605601
• Device Lot Number: 65521850
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG