MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Ossification (1428); Necrosis (1971); Pain (1994); Osteolysis (2377)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00814, 0001825034-2023-00815, 0001825034-2023-00816, and 0001825034-2023-00818.Medical devices: unknown femoral catalog#: ni lot#: ni, unknown tibial insert catalog#: ni lot#: ni, unknown i-beam tibial tray catalog#: ni lot#: ni, unknown cement plug catalog#: ni lot#: ni.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 Description

It was reported a patient had a left total knee arthroplasty.Subsequently, began experiencing pain and stiffness.Radiographic imaging displayed radiolucency and osteolysis.Approximately seventeen years post-implantation, underwent a revision for aseptic femoral loosening and poly wear.During the revision, found avascular necrosis and flattening of the patellar component.Approximately half of the patella had flattened off and created with a large osteophyte on the lateral side, clearly rubbing on the prosthesis.All components were removed a persona revision system was implanted without complication.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified that the patient experienced pain, with a mild stiffness issue.X-ray found femoral loosening with poly wear.Revision surgery was performed, and no intra-operative complications were noted.However, during the surgery, avascular necrosis was noted with flattening of the patellar component.Approximately half of the patella had flattened off and created a large osteophyte on the lateral side.It was excised as it was clearly rubbing on the prosthesis.All the implants were replaced.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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: UNKNOWN PATELLA
• 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: 16756120
• MDR Text Key: 313452701
• Report Number: 0001825034-2023-00817
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 06/01/2023

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White