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

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problems Failure of Implant (1924); No Code Available (3191); Hyperextension (4523)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported right knee arthroplasty and after 10 years was revised due to instability, hyperextension and fracture of the hinge or pe-sleeve.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).

Event Description

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

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual inspection of the returned product found the inlay has fractured.The device was sent to sem for further analysis.The analysis concluded that although it is possible that some of the observed damage may have been incurred during the explantation process, the fracture on the edge of the post pocket is possible due to overloading, possibly occurring after the reported breakage of the hinge in vivo.Dhr was reviewed and no discrepancies were found.Analysis of the fractured device suggested an overload fracture failure, however a definitive root cause cannot be determined.A summary of the investigation was sent to the customer.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.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW SIZE F 12 MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10987067
• MDR Text Key: 220895471
• Report Number: 0001822565-2020-04068
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00588006012
• Device Lot Number: 61222608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN FEMORAL COMPONENT.; UNKNOWN TIBIAL COMPONENT.
• Patient Outcome(s): Hospitalization; Required Intervention