MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 2; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported a patient was revised due to hinge post was dislocated from rotating hinge knee femoral hinge and articular surface was dislocated from tibial component.Attempts have been made, but there is no additional information at this time.

Manufacturer Narrative

(b)(4).Concomitant devices: articular surface with hinge post extension size e 20 mm height catalog #: 00588005020 lot #: 63275666; tibial component precoat size 2 catalog #: 00588000200 lot #: 64146578; articular surface with segmental hingepost size e 20 mm height catalog #: 00598801212 lot #: 63449950; femoral component option for cemented use only size e left catalog #:00588001501 lot #: 64366815.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple reports were filed for this event, please see associated reports: 0001822565 - 2021 - 01943, 0001822565 - 2021 - 01965, 0001822565 - 2021 - 01942.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The results of the investigation are as follows: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 SIZE 2
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12869495
• MDR Text Key: 281210851
• Report Number: 0001822565-2021-03334
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024198968
• UDI-Public: (01)00889024198968(17)240131(10)64146578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00588000200
• Device Lot Number: 64146578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female