MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FINN TIBIAL TRAY; PROSTHESIS KNEE

Model Number N/A

Device Problems Unstable (1667); Osseointegration Problem (3003)

Patient Problems Osteolysis (2377); Patient Problem/Medical Problem (2688)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products - catalog #: unknown, unknown finn bearing, lot # unknown; catalog #: unknown, unknown finn stem, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.The device history record was unable to be reviewed due to no lot or item number being provided root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.External radiologist reviewed provided x-rays and noted that there is extensive osteolysis and abnormal lucency along the tibial component and stem component shows valgus angulation.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 multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04473, 0001822565-2018-03966.Remains implanted.

Event Description

It was reported that the patient required a knee revision of the bearing and polyethylened hinge components approximately 18 years post implantation due to wear.It was also reported the patient was experiencing instability.

Manufacturer Narrative

(b)(4).There was no wear.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: UNKNOWN FINN TIBIAL TRAY
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7759777
• MDR Text Key: 116363077
• Report Number: 0001822565-2018-03964
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• 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): Hospitalization; Required Intervention