MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LCCK NEXGEN LOCKING SCREW STRIPED PURPLE ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: hi-fatigue bone cmt catalog # 00112114001, lot # 22ka18510.Tibial block and screws catalog # 00598800226, lot # 64278437.Tibial block and screws catalog # 00598800227, lot # 65578208.Femoral component catalog # 00599401392 ,lot # 64903876.Stemmed tibial component catalog # 00598002702, lot # j7370864.Stem extension catalog # 00598801012, lot # 65672620.Stem extension catalog # 00598802011, lot # 65672620.Stem extension catalog # 00598801012, lot # 65584553.G2: france.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure one years post implantation due to device screw had become unsuitable and the thread was defective.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of being implanted in the form of nicks, gouges, and the body around the articular surface is deformed.Evaluation of the support screw found the head of the screw was fracture off.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: LCCK NEXGEN LOCKING SCREW STRIPED PURPLE ARTICULAR SURFACE
• 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: 19816621
• Report Number: 0001822565-2024-02445
• Device Sequence Number: 12931516
• Product Code: JWH
• UDI-Device Identifier: 00889024224889
• UDI-Public: (01)00889024224889(17)271129(10)65712586
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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 Model Number: N/A
• Device Catalogue Number: 00599402214
• Device Lot Number: 65712586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female