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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CON LNR 0DEG 26ID 50-52OD SZ E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED
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SMITH & NEPHEW, INC. CON LNR 0DEG 26ID 50-52OD SZ E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number 71323114
Medical Device Problem Code Device Damaged by Another Device (2915)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/24/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a surgery was delayed by more than one hour due to the locking mechanism on the ring breaking when impacted.
 
Additional Manufacturer Narrative
Please see attached file for the investigation results.(b)(4).
 
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Brand Name
CON LNR 0DEG 26ID 50-52OD SZ E
Common Device Name
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6577038
Report Number1020279-2017-00350
Device Sequence Number905677
Product Code KWZ
UDI-Device Identifier03596010510884
UDI-Public03596010510884
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K033442
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/28/2017
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 Expiration Date06/11/2026
Device Catalogue Number71323114
Device Lot Number16FM09970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Initial Date Received by Manufacturer 04/24/2017
Supplement Date Received by Manufacturer04/24/2017
Initial Report FDA Received Date05/18/2017
Supplement Report FDA Received Date09/28/2017
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;
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