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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 58MM GROUP G HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 58MM GROUP G HIP COMPONENT Back to Search Results
Model Number DSPCGG58
Device Problems Material Disintegration (1177); Noise, Audible (3273); Migration (4003)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description

Allegedly the patient was revised due to mom complications: severe hip pain; elevated metal levels of cobalt and chromium; evidence of subsidence of the stem; metallosis; and clicking (right).

 
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Brand NameDYNASTY® PC SHELL 58MM GROUP G
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 Key8838391
MDR Text Key152551646
Report Number3010536692-2019-00922
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDSPCGG58
Device Catalogue NumberDSPCGG58
Device LOT Number049846164
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/22/2019
Event Location No Information
Date Manufacturer Received07/22/2019
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: 07/29/2019 Patient Sequence Number: 1
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