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

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: ----------------------------------------- 00588001401 fem size d left lot# 60260466, 00599003421 distal only femoral augment block precoat lot# 60210767, 00599003420 prc agmt block dist sz d 10mm lot# 60326217, 00599003401 prc agmt block post sz d 5mm lot# 60328336, 00599003423 femoral augment block distal only precoat size d 15 lot# 53680100, 00599003423 femoral augment block distal only precoat size d 15 lot# 53680100.

Event Description

It was reported a patient had a revision of a left total knee arthroplasty.Subsequently, eighteen years post procedure, the patient was revised due to instability.Articular surface was revised.No additional details were provided.

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.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: size 2 tibial is not compatible with articular surface which fits with size 3,4,5,6 tibial plate and femur size d.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial surgery found no complication during the surgery.No medical record was provided for this reported event.X-ray review found left total knee arthroplasty with possible hinged prosthesis and tibial and patellar cerclage wires.Overall, sizing appears to be within normal limits.No joint effusion.No fracture.Question radiolucency along the bone cement interface of the femoral stem.The root cause of the reported instability issue could be attributed to incompatible components as the surgeon used tibial plate size 2 with this articular surface.The product label indicates that this articular surface should be used with tibial plate size 3, 4, 5, 6.Additionally, instructions for use indicates that the risk of implant failure is higher with inaccurate component alignment or positioning.Complaint confirmed based on the compatibility check.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 Description

No further event information available at the time of this report.

• Brand Name: 12MM HEIGHT SIZE D 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: 17350659
• MDR Text Key: 319307624
• Report Number: 0001822565-2023-01965
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 00588004012
• Device Lot Number: 60209716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2004
• 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: Female