MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE 8 MM SERIES 4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown date more than 15 years ago.Medical devices: unknown mg unicondylar femoral catalog#: ni lot#: ni, unknown mg unicondylar tibial tray catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right partial knee revision due to poly wear fifteen years post implantation.The patient had a loose body that had fractured from his natural patella that was also removed, and it may have contributed to the wear.Attempts have been made and no further information has been provided.

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.Reported event was confirmed by review of photograph.Visual examination of the provided picture confirms wear of the articular surface.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: TIBIAL ARTICULAR SURFACE 8 MM SERIES 4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10271633
• MDR Text Key: 198911323
• Report Number: 0001822565-2020-02555
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K880155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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: 00578807008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR