MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE F 14 MM HEIGHT; PROSTHESIS, KNEE

Model Number 00-5850-060-14

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision right total knee arthroplasty to replace a disassociated hinge post.A polyethylene bearing was implanted with a hinge post packaged with another device.Approximately four and a half months post implantation, the hinge post of the articular surface backed out for a second time.The patient again underwent revision surgery to replace the articular surface and hinge post mechanism.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).It was reported that the articular surface from this device was implanted at the time of disassociation.Concomitant medical products: articular surface with hinge post extension screw enclosed do not discard size f 14 mm height: catalog#: 00588006014, lot#: 64000583; unknown rotating hinge knee femoral component: catalog#: ni, lot#: ni; unknown rotating hinge knee tibial tray: catalog#: ni, lot#: ni.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2022-03241.Customer has indicated that the product will not be returned to zimmer biomet for evaluation per hospital policy.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE SIZE F 14 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15814934
• MDR Text Key: 303818347
• Report Number: 0001822565-2022-03240
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024196247
• UDI-Public: (01)00889024196247(17)250630(10)63694355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-5850-060-14
• Device Catalogue Number: 00585006014
• Device Lot Number: 63694355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male