MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW SIZE STRIPED GREEN 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices - nexgen option femoral component size g right, catalog #: 00599401792, lot #: 63493582, nexgen stemmed precoat tibial component size 5, catalog #: 00598004701, lot #: 63544293, nexgen distal femoral augment block size f 5mm, catalog #: 00599003610 lot #: 63582574, nexgen distal femoral augment block size f 5mm, catalog #: 00599003610 lot #: 63557591, nexgen posterior augment block size f 5mm, catalog #: 00599003601 lot #: 63452087, nexgen straight stem extension 13mm x 100mm, catalog #: 00598801013 lot #: 63566684, nexgen straight stem extension 18mm x 100mm, catalog #: 00598801018 lot #: 63552484.Foreign source: sweden.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address post-operative fracture and migration of the articular surface screw as well as pain, swelling and a clicking noise while walking approximately thirty (30) months post-operatively.Initial operative notes noted no intraoperative complications during implantation.Revision operative notes noted that the migrated screw was found anteriorly and was deformed.The articular surface was loose, but the tibial and femoral components were well-fixed.The patellar component appeared to be damaged locally, however, the rest of the component remained undamaged.Scratches were also identified on the femoral component and metal was found in the synovium, requiring a partial synovectomy.When the surgeon opened a new articular surface, the new screw appeared visually longer than the old one, creating suspicion that the screw had fractured.The surgeon was unable to get good fixation with the new articular surface screw and decided intraoperatively to revise the entire construct.No further intraoperative complications were noted.
Additional Manufacturer Narrative
Upon receiving additional information found during investigation of the reported event, it was determined that the event had been previously reported under mdr: 0001822565-2020-00223.All subsequent information/investigation will be processed through the original mdr number.This report should be voided.
Event or Problem Description
Upon receiving additional information found during investigation of the reported event, it was determined that the event had been previously reported under mdr: 0001822565-2020-00223.All subsequent information/investigation will be processed through the original mdr number.This report should be voided.

• Brand Name: NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW SIZE STRIPED GREEN 12MM
• Common Device Name: 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: 15447571
• Report Number: 0001822565-2022-02680
• Device Sequence Number: 4729804
• Product Code: JWH
• UDI-Device Identifier: 00889024225275
• UDI-Public: (01)00889024225275(17)240731(10)63422524
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00599404212
• Device Lot Number: 63422524
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male