MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIOMET OSS BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/07/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown oss femoral component, catalog # unknown lot # unknown, unknown oss assembly catalog# unknown, lot # unknown, unknown oss stem, catalog # unknown lot # unknown, unknown oss stem, catalog # unknown lot # unknown, unknown oss tibial tray, catalog # unknown lot # unknown, unknown palacos bone cement : catalog # unknown lot # unknown.Initial reporter: ben molenaers, nele arnout, johan bellemans ¿complex total knee arthroplasty using resection prosthesis at mid-term follow-up¿ department of orthopaedics and traumatology ¿ the knee (2012) 550-554.(b)(4).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.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: 0001825034-2017-05577, 0001825034-2017-05578, 0001825034-2017-05579, 0001825034-2017-05580, 0001825034-2017-05581.

Event Description

It was reported in a journal article that six (6) patients post operative final follow-up score was rated as poor.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: unknown oss femoral component, catalog # unknown lot # unknown ; unknown oss assembly catalog# unknown, lot # unknown ; unknown oss stem, catalog # unknown lot # unknown ; unknown oss stem, catalog # unknown lot # unknown ; unknown oss tibial tray, catalog # unknown lot # unknown ; unknown palacos bone cement : catalog # unknown lot # unknown ; unknown patella: catalog# unknown lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05577 , 0001825034-2017-05578 , 0001825034-2017-05579 , 0001825034-2017-05580 , 0001825034-2017-05581, 0001825034-2017-06798, 0001825034-2017-06798.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.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: UNKNOWN BIOMET OSS BEARING
• 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: 6762847
• MDR Text Key: 81691183
• Report Number: 0001825034-2017-05576
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 08/02/2017
• 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): Other