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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71336500
Medical Device Problem Code Misconnection (1399)
Health Effect - Clinical Code Injury (2348)
Date of Event 08/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the liner had difficulty seating and would not stay locked inside shell.After trying other shell and liner, they realize the missfitting device was the hole cover.This caused a delay in the surgery greater than 30 minutes.
 
Additional Manufacturer Narrative
Please review attached for investigation results.
 
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Brand Name
REF THREADED HOLE COVER
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6849207
Report Number1020279-2017-00717
Device Sequence Number16524638
Product Code MBL
UDI-Device Identifier03596010197634
UDI-Public03596010197634
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
K070756
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/08/2017
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 Catalogue Number71336500
Device Lot Number17GM12362
Initial Date Received by Manufacturer 08/22/2017
Supplement Date Received by Manufacturer08/22/2017
Initial Report FDA Received Date09/07/2017
Supplement Report FDA Received Date11/08/2017
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; Other;
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