MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION SIZE F RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03161, 0001822565-2023-03162.D10 medical device: unknown tibial insert catalog#: ni lot#: ni.Unknown tibial tray catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right knee arthroplasty.Subsequently, patient reports pain, audible noise, instability, and falls while walking.The patient has been using a cane for assistance.No revision procedure has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 001822565-2023-03161, 0002648920-2023-00323, 0002649820-2023-00322, 001822565-2023-03827, and 001822565-2023-03828.D10 medical devices: articular surface size ef 12 mm height catalog#: 00596205112, lot#: 62150065; stemmed nonaugmentable tibial component option cr/ps/lps size 7 catalog#: 00598605701 lot#: 62213003; all poly patella standard cemented size 38 mm diameter 9.5 mm thickness catalog#: 00597206538, lot#: 62425602; palacos r 1x40 single catalog#: 00111214001, lot#: 77864368; palacos rg 1x40 single catalog#: 00111314001, lot#: 76404338.

Event Description

It was reported patient underwent right total knee arthroplasty.Approximately eight years later, patient started having pain, popping, weakness, swelling, stiffness, instability, and locking/catching.X-ray indicated some lucency of the tibial component.No treatment occurred at this time.Two months later, the patient reported the knee sticking, and that they had fallen due to the knee giving out when twisting and pivoting.Upon exam the knee had an audible clunk when flexed.Ct and bone scans continued to indicate minimal radiolucency between the tibial tray and cement.No revision procedure has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Suggested component code: mechanical (g04) - femur.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: ambulates well without assistive device, x-ray: good position and stable without complications, pain, popping, instability, weakness, locking/catching, swelling, stiffness, minimal lucency on ap view, possible failed right tka on the basis of loosening vs structural damage to the poly, stem component of the tibial component is normal, as is the femoral component, alignment is anatomic, no evidence of fracture, patient has fallen and ambulates with a cane, patient feels a "shift and clunk¿.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.The patient reported falling.However, with the information provided, it is unknown the cause of the fall.A summary of the investigation has been sent to the complainant.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.

Event Description

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

• Brand Name: FEMORAL COMPONENT OPTION SIZE F RIGHT
• Type of Device: 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: 18124408
• MDR Text Key: 327997077
• Report Number: 0001822565-2023-03163
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00599601652
• Device Lot Number: 62482443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• 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
• Treatment: SEE H10.; SEE H10.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 95 KG