MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM HEIGHT SIZE F ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 02/06/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a knee surgery and was implanted with zimmer biomet components.Subsequently, the patient underwent a revision approximately 9 years later due to instability and dislocation.The rhk articulate surface was exchanged with an unknown component.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 00598800626 - tibial block and screws precoat size 6 5 mm thickness - 61193722.00598801020 - stem extension straight 20mm dia x 100mm length(combined length 145mm) - 37214054.00598801118 - stem extension straight long 18mm dia x 155mm length (combined length 200mm) - 62396156.00598800626 - tibial block and screws precoat size 6 5 mm thickness - 61280440.66017790 - copal g + c 1x40 - 77454358.00588000600 - size 6 precoat cemented tibial component - 62333881.00545001930 - trabecular metal femoral diaphyseal cone, 30mm, large, left - 62328507.00599003602 - prc agmt block post sz f 10mm - 62242498.00599003602 - prc agmt block post sz f 10mm - 62242498.00599003620 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 10 mm augment with screw - 61988768.00597206541 - all poly patella standard cemented size 41 mm diameter 10.0 mm thickness - 60721066.00599003620 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 10 mm augment with screw - 61943771.00588001601 - left size f cemented option femoral component femoral plastic cap must be removed prior to implantation - 61974996.G2 : foreign country : switzerland.The pictures provided were insufficient to perform a visual or dimensional evaluation.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified: possible disengagement of the hinge mechanism as well as the polyethylene liner, failure of rhk-hinge post extension, instability, dislocation and easing.A definitive root cause cannot be determined.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.

• Brand Name: 12MM HEIGHT SIZE F ARTICULAR SURFACE WITH HINGE POST EXTENSION
• Type of Device: 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: 16806333
• MDR Text Key: 313911473
• Report Number: 0001822565-2023-01105
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00588006012
• Device Lot Number: 62470386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 111 KG