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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Event or Problem 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
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11096675
• Report Number: 0001822565-2020-04263
• Device Sequence Number: 14440664
• Product Code: KRO
• UDI-Device Identifier: 00889024199132
• UDI-Public: (01)00889024199132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• 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
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/15/2021; 03/01/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/04/2021; 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention