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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 22 + 4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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SMITH & NEPHEW, INC. COCR 12/14 FEM HD 22 + 4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71302204
Device Problem Physical Resistance/Sticking
Event Date 11/16/2018
Event Type  Injury  
Event Description

Dr (b)(6) performed a hemiarthroplasty on his patient using the above implants. Once the hip was reduced he noted that there was no movement between the 22mm femoral head and the tandem shell, effectively negating the benefit of using a bi-polar construct. Even on moving the articulating surface by hand the components were very stiff and resistant to free movement. Revision surgery was performed on (b)(6) 2018.

 
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Brand NameCOCR 12/14 FEM HD 22 + 4
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis , TN 38116
0447940038
MDR Report Key8394763
Report Number1020279-2019-00910
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71302204
Device LOT Number15JM08793
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/14/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/06/2019 Patient Sequence Number: 1
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