MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA STANDARD CEMENTED SIZE 38 MM DIAMETER 9.5 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem 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: 001822565-2023-03161, 0002648920-2023-00323, 001822565-2023-03163, 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 femoral component option size f right catalog#: 00599601652 lot#: 62482443 palacos r 1x40 single catalog#: 00111214001 lot#: 77864368 palacos rg 1x40 single catalog#: 00111314001 lot#: 76404338 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 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.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: ALL POLY PATELLA STANDARD CEMENTED SIZE 38 MM DIAMETER 9.5 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18418696
• MDR Text Key: 331601250
• Report Number: 0002648920-2023-00322
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00597206538
• Device Lot Number: 62425602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 95 KG