MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE D 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: partial femur cemented size 6 left medial; p/n: 42558000601, l/n: 62477806; partial tibial cemented size d left medial; p/n: 42538000401, l/n: 63607192.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product location is unknown.

Event Description

It was reported the patient underwent an initial knee arthroplasty 1 month post-implantation due to infection.Subsequently, the inlay was revised.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.The op report stated revision due to periprosthetic early infection with lying medial unicondylar prosthesis.Visual inspection of the returned bearing exhibits wear (nicks and gauges) indicating signs of use.Dhr 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.

Event Description

It was reported patient underwent a revision procedure one month post-implantation due to infection.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE D 8 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7809939
• MDR Text Key: 118021999
• Report Number: 0001822565-2018-04614
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42518200408
• Device Lot Number: 63449770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/14/2019
• 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 Weight: 104