MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT SIZE D RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - nexgen rotating hinge knee articular surface catalog #: 00588004012 lot #: 64382844, nexgen all poly patella standard size 35 catalog #: 00597206535 lot #: 64325356, nexgen straight stem extension 11mm x 100mm catalog #: 00598801011 lot #: 64413907, nexgen straight stem extension 13mm x 1000mm catalog #: 00598801013 lot #: 64454566, nexgen precoat tibial component size 3 catalog #: 00588000300 lot #: 64393895 report source - foreign: (b)(6).The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2020-02382.

Event Description

It is reported that the patient underwent a knee arthroplasty revision to address pain and unscrewing of the hinge prosthesis.Attempts have been made and no additional information is available.

Manufacturer Narrative

The product was evaluated and the reported event was confirmed through review of medical records.The returned articular surface and post showed signs of having been implanted (gouged/nicked/worn), while the post additionally showed striations on the shaft and damage to the threads.The root cause remains undetermined at this time.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.

Event Description

It is reported that the patient underwent a knee arthroplasty revision to address pain and unscrewing of the hinge prosthesis.Initial operative notes identified no intraoperative complications.Revision operative notes reported that the patient presented with "cracking" in the knee and was diagnosed with dislocation of the hinge.During the procedure, the dislocation of the prosthesis was confirmed, as the hinge screw was completely unscrewed and free within the joint.

• Brand Name: NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT SIZE D RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11096675
• MDR Text Key: 224430809
• Report Number: 0001822565-2020-04263
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024199132
• UDI-Public: (01)00889024199132
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 00588001402
• Device Lot Number: 64230855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention