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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 71302608
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/13/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation and pain.It was reported that the outer cup of bipolar was dislocated when diaclasis occurred.
 
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Brand Name
COCR 12/14 FEM HD 26 + 8
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10033419
Report Number1020279-2020-01517
Device Sequence Number2956294
Product Code LPH
UDI-Device Identifier03596010194091
UDI-Public03596010194091
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K963509
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/09/2020
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 Number71302608
Device Catalogue Number71302608
Device Lot Number19KM10652
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/13/2020
Supplement Date Received by Manufacturer12/07/2020
Initial Report FDA Received Date05/07/2020
Supplement Report FDA Received Date12/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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