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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG LONG COBALT CHROME HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG LONG COBALT CHROME HIP COMPONENT Back to Search Results
Model Number PHAC1234
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to aseptic loosening stem and adverse soft tissue reaction to particle debris. Revision njr number: 4458878. Side:l. Primary asa: p1 - fit and healthy. Components not revised: procotyl l beaded and ha coated cup size 50mm, product id: pha06260, lot id: 1521597. Rim-lock biolox delta ceramic liner 32mm id group d, product id: pha04508, lot id: 1549402.
 
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Brand NamePROFEMUR NECK A/R 8DG LONG COBALT CHROME
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 Key10335406
MDR Text Key202738969
Report Number3010536692-2020-00501
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K091423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPHAC1234
Device Catalogue NumberPHAC1234
Device Lot Number1564800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2020
Event Location No Information
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: 07/28/2020 Patient Sequence Number: 1
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