MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 71MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060)

Event Date 12/03/2009

Event Type  Injury  

Event Description

It was reported that a patient had an initial left total knee arthroplasty.Subsequently 1.5 years later, the patient had experienced pain and recurrent effusions since the initial surgery and the patient underwent a revision.They found synovium inflamed which was consistent with the recurrent effusions and stress shielding behind the tibial and femoral components.A complete synovectomy was performed, inflamed hypertrophic scar tissue was excised, and all implants, except the patella, were revised without complication.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).D10: 183030 - vanguard cr ilok fem-lt 67.5 - 937520.189060 - vngd ant stblzd brg 10x71 - 822470.11-150842 - bmet arcom ap pat 3pst 34mm md - 171810.402433 - cobalt-g hv bone cement 40gm b - 952700.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02864.0001825034-2023-02866.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no intra-operative complication noted during initial and revision surgeries.On revision op note states that the patient had effusion and pain.Bone scan demonstrated quite a bit of uptake around femoral component and increased amount during the blood flow phase.No obvious signs of loosening, inflammatory synovium consistent with recurrent effusions.Surgeon noted that ''behind the tibial and femur had some evidence of stress shielding and it was better than anticipated and was similar to the type we would see behind the press-fit device'' and removed scar tissues.A definitive root cause cannot be determined.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 Description

No further event information available at the time of this report.

• Brand Name: BIOMET CC CRUCIATE TRAY 71MM
• Type of Device: 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: 18266065
• MDR Text Key: 329722583
• Report Number: 0001825034-2023-02865
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 141233
• Device Lot Number: 093040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male