MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant has indicated that the product will not be returned because of hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reference report: 0002648920 - 2021 - 00185.Investigation incomplete.
Event or Problem Description
It was reported that patient underwent revision procedure due to unknown patella issues.The patella and bearing were removed and replaced.It was noted that the locking screw was not implanted during the initial procedure.There is no additional information available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.It was determined during the revision procedure that there was no locking screw in the bearing which is considered to be off label use.The root cause of the reported event remains unknown, as the patella was revised for unknown reasons.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.
Event or Problem Description
No additional information reported.

• Brand Name: NEXGEN ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW
• Common Device Name: 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: 12304665
• Report Number: 0001822565-2021-02077
• Device Sequence Number: 3841289
• Product Code: JWH
• UDI-Device Identifier: 00889024211391
• UDI-Public: (01)00889024211391(17)210630(10)63353210
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00596204217
• Device Lot Number: 63353210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male