MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN FINN FEMORAL STEM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 06/10/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).John h.Healey (2009) " early equivalence of uncemented press-fit and compress femoral fixation", 467:2792-2799.Event date ¿ the journal article was published in 2009.Contact name ¿ this journal article was written by german l.Farfalli, patrick j.Boland, carol d.Morris, edward a.Athanasian and john h.Healey.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Event Description

It is reported in a journal article that eleven (11) patients underwent knee arthroplasty revisions between 3 and 142 months post-operatively due to aseptic loosening of the femoral stem.Attempts have been made to retrieve additional information, but no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Upon reassessment of the reported event, it was determined to be not reportable as this component is not confirmed to be zimmer biomet product.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products - unknown finn bearing, unknown finn tibial tray, unknown finn tibial stem, unknown finn femoral.After further review it was determined that the product reported does require a report as the product is of zimmer biomet design control.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05753, 0001825034-2017-0649.

• Brand Name: UNKNOWN FINN FEMORAL STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6766798
• MDR Text Key: 81834769
• Report Number: 0001825034-2017-05753
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2017
• 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