MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 2; PROSTHESIS, KNEE

Model Number N/A

Device Problems Naturally Worn (2988); Migration (4003)

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item 00584202208, lot 63355036.Item 00584201302, lot 63777152.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02002.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient received a total knee arthroplasty and approximately one year after the procedure the patient experienced pain and swelling and was revised two years after the initial procedure due to dislodge and poly wear.It was noted significant findings of a compartmental arthroplasty with joint space loss of the medial compartment and inferior depression of the tibial.Attempts have been made and no further information has been received.

Manufacturer Narrative

(b)(4).Visual evaluation of the returned tibial tray found signs of being implanted with remains of bone cement and bone ingrowth and scratches on the proximal and distal surfaces and an edge is worn down.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.X-rays were provided and reviewed by a health care professional.Review found joint space loss of the medial compartment and inferior depression of the tibial plateau component (subsidence), resulting in genu varus.Overall bone quality appears normal.A definitive root cause cannot 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: TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 2
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10161920
• MDR Text Key: 195372665
• Report Number: 0001822565-2020-02001
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 00584200202
• Device Lot Number: 63563611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR