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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS UNKNOWN BIOMET OSS BEARING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 10/07/2011
Event Type  Injury  
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.
 
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.
 
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Brand NameUNKNOWN BIOMET OSS BEARING
Type of DevicePROSTHESIS, 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 Key6762847
MDR Text Key109915777
Report Number0001825034-2017-05576
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received08/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2017
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 NumberN/A

Patient Treatment Data
Date Received: 08/03/2017 Patient Sequence Number: 1
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