MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT HIGH FLEX PRECOAT FOR; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problems Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item#:00584200402; tibial component precoat, lot#:61859767.Item#:00584202409; articular surface size 4 9 mm, lot#:unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01034, 0001822565-2020-01035.

Event Description

It was reported by patients legal counsel the patient underwent a right unicompartmental knee arthroplasty and was revised approximately 7 years later due to pain, radiolucency, femoral component fracture, loosening, and osteolysis.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 reported event was confirmed by review of photograph and medical records.Visual evaluation of the provided photography confirmed that the femoral implant was fractured.No other visual damage can be noted from the picture.However, the product was not returned for further evaluation.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during the initial surgery.Office visits note from (b)(6) 2019, the patient presented with pain, the x-ray found radiolucent line seen on the later view indicating fractured femoral component and loosening of the tibial plate.Bone scan and ct scan found femoral component loosening.The patient had difficulty ambulating and using assist devices for walking.Revision surgery was taken place on (b)(6)2019.During surgery, the femoral and tibial component was easily removed and the femoral component was grossly loose with extensive osteolysis in the femoral condyle.A definitive root cause cannot be determined.Per package insert, pain, fracture, loosening, and osteolysis are known adverse effects of this system.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional information provided does not alter previous investigation conclusions.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 at time of this report.

• Brand Name: FEMORAL COMPONENT HIGH FLEX PRECOAT FOR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9865500
• MDR Text Key: 188658955
• Report Number: 0001822565-2020-01033
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 00584201502
• Device Lot Number: 61975145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2012
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG