MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2019-04750.Concomitant medical products partial articular surface right medial, item# 42528200409, lot# 63887348.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that, during a unicompartmental knee arthroplasty procedure, an articular surface would not seat to the tibial tray.The surgeon removed the articular surface and tried to insert it multiple times.Although the articular surfaces seemed to mate with the tibial tray, there was concern that the surface was damaged and a backup articular surface was used to complete the procedure.There is no additional information at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9217742
• MDR Text Key: 167208679
• Report Number: 3007963827-2019-00301
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000402
• Device Lot Number: 64318523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1