MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ART SURFACE WITH HINGE POST EXTENSION SCREW ENCLOSED SIZE F 17 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: tibial full block augment precoat size 6 10 mm thickness catalog#: 00588000610 lot#: 62591593.Tibial central cone size large catalog#: 42545000513 lot#: 64700936.Tibial component precoat size 6 catalog#: 00588000600 lot#: 64375444.Stem extension straight 15mm dia x 100mm length catalog#: 00598801015 lot#: 64258386.Femoral central cone size large catalog#: 42545001013 lot#: 64643092.Stem extension straight 15mm dia x 100mm length catalog#: 00598801015 lot#: 64082243.Femoral component option size f left catalog#: 00588001601 lot#: 64927752.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 the patient underwent a left knee procedure.Subsequently, the patient was revised after the thread on the hinge post extension fractured, leading to the post extension backing out, and the knee to dislocate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified the articular surface shows signs of being implanted (gouged/nicked).The returned hinge extension post has striations on the shaft with damage to the threads.A portion of the threads are also fractured off.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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: ART SURFACE WITH HINGE POST EXTENSION SCREW ENCLOSED SIZE F 17 MM HEIGHT
• 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: 15552172
• Report Number: 0001822565-2022-02876
• Device Sequence Number: 6180884
• Product Code: JWH
• UDI-Device Identifier: 00889024199446
• UDI-Public: (01)00889024199446(17)231130(10)64174113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 01/31/2023

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588006017
• Device Lot Number: 64174113
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG