MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-FINN-BEARINGS-UNK; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted retrospectively per fda request.D6a: approximately 18 years ago.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Review of the x-ray evaluation report shows evidence of extensive osteolysis and extensive abnormal lucency along the tibial component.The constrained long stem components demonstrate valgus angulation at the joint level.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.

Event Description

It was reported that the patient underwent a revision surgery approximately 18 years post implantation due to wear.It was noted that the patient was experiencing instability.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This report should be voided.It was filed in error as a duplicate of 0001825034-2018-04473.

Event Description

This report should be voided.It was filed in error as a duplicate of 0001825034-2018-04473.

• Brand Name: KNE-FINN-BEARINGS-UNK
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16964070
• MDR Text Key: 315582089
• Report Number: 0001825034-2023-01144
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization