MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT HIGH FLEX PRECOAT FOR CEMENTED USE ONLY RIGHT MEDIAL/LEFT LATE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04143, 0001822565-2019-02472.Concomitant medical products - articular surface size 1 10 mm height femoral size a,b,c,d,e,f,g catalog#: 00584202110 lot#: 62686349, tibial component precoat right medial/left lateral size 1 catalog#: 00584200102 lot#: 62686349, stryker simplex bone cement with tobramycin, stryker asymmetric patella.Reported event was confirmed by review of radiographs.Radiographs were provided and reviewed by a health care professional.Review of the available records identified extensive osteolysis and subsequent loosening was present along the margins of the tibial and femoral components of the right knee medial unicompartmental arthroplasty.The femoral component was also noted to be obliquely oriented and the tibial component appears partially subsided and abnormally positioned on the ap view.Device history record was reviewed and no discrepancies were found.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.[mw5078077.Pdf].

Event Description

It was reported that patient underwent a partial knee arthroplasty procedure.Subsequently, patient started experiencing pain on the outside of the affected right knee.Surgeon stated that the device had loosened.Review of radiographs indicated loosening of the femoral and tibial tray, as well as osteolysis.Patient was revised with all prostheses removed approximately two years one month post operative.

• Brand Name: FEMORAL COMPONENT HIGH FLEX PRECOAT FOR CEMENTED USE ONLY RIGHT MEDIAL/LEFT LATE
• 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: 8699805
• MDR Text Key: 148035393
• Report Number: 0001822565-2019-02473
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2019

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
• Device Catalogue Number: 00584201202
• Device Lot Number: 63006783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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 Weight: 64