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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M HIP COMPONENT Back to Search Results
Model Number PHA04410
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problem Missing Value Reason (3192)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative

This event will be updated when investigation is complete.

 
Event Description

Allegedly primary surgery was performed on (b)(6) 2019. Two weeks after the operation, the patient pointed out that "the rattle noise occurs in the body", and the sound disappeared a few days later, but when ct was taken, the 32 mm head was acetabular. Because it was at a position offset from the lid cup, it is presumed that the polyethylene liner was likely to be dislocated, and day 21 poly liner removal + replacement surgery was performed.

 
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Brand NameFEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M
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 Key8798022
MDR Text Key151288286
Report Number3010536692-2019-00905
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeJP
PMA/PMN NumberK130376
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 02/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPHA04410
Device Catalogue NumberPHA04410
Device LOT Number1789272
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/25/2019
Event Location No Information
Date Manufacturer Received06/25/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/17/2019 Patient Sequence Number: 1
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