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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. RIM-LOCK BIOLOX DELTA CERAMIC LINER HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. RIM-LOCK BIOLOX DELTA CERAMIC LINER HIP COMPONENT Back to Search Results
Model Number PHA0-4510
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

This complaint will be updated once investigation is complete. Trends will be evaluated.

 
Event Description

Allegedly, biolox liner fractured after patient reached down to pick up grandchild. Head, stem and shell remained intact. Liner and head were revised.

 
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Brand NameRIM-LOCK BIOLOX DELTA CERAMIC LINER
Type of DeviceHIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key7514576
MDR Text Key108268657
Report Number3010536692-2018-00618
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberPHA0-4510
Device Catalogue NumberPHA0-4510
Device LOT Number1711547
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/09/2018
Event Location No Information
Date Manufacturer Received05/09/2018
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/15/2018 Patient Sequence Number: 1
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