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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Reaction (2414)
Type of Reportable Event Serious Injury
Event or Problem 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 Name
PROFEMUR NECK A/R 8DG LONG COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10335406
Report Number3010536692-2020-00501
Device Sequence Number14346233
Product Code JDL
UDI-Device IdentifierM684PHAC12341
UDI-PublicM684PHAC12341
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberPHAC1234
Device Catalogue NumberPHAC1234
Device Lot Number1564800
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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