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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOLOX DELTA OPTION HIP SYSTEM CERAMIC HEAD HIP PROSTHESIS

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BIOMET ORTHOPEDICS BIOLOX DELTA OPTION HIP SYSTEM CERAMIC HEAD HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Physical Resistance
Event Date 12/09/2016
Event Type  Malfunction  
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. (b)(4). This report is number 2 of 2 mdrs filed for this event (reference 1825034-2016-05400 & 05401).

 
Event Description

During a procedure, the femoral head did not move smoothly within the acetabular liner. Another head and liner were used to complete the procedure.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-05401-1.

 
Manufacturer Narrative

Complaint sample was evaluated. Visual inspection of the parts found no damage that would prevent the head from freely articulating. The parts were assembled and the head articulated appropriately. The compliant therefore cannot be confirmed as the returned products functioned as intended. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Root cause of the event could not be determined. 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.

 
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Brand NameBIOLOX DELTA OPTION HIP SYSTEM CERAMIC HEAD
Type of DeviceHIP PROSTHESIS
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 Key6229779
Report Number0001825034-2016-05400
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number650-1055
Device LOT Number096950
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/18/2015
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

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