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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIAL 20 DEG 32MM 58-60 OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. TRIAL 20 DEG 32MM 58-60 OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71363258
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/20/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during surgery, trial broke.Had backup, no delay reported.Device malfunctioned within the patient, all pieces removed.No injury,.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
TRIAL 20 DEG 32MM 58-60 OD
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8457332
Report Number1020279-2019-01226
Device Sequence Number354761
Product Code JDI
UDI-Device Identifier03596010534330
UDI-Public03596010534330
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K123598
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number71363258
Initial Date Received by Manufacturer 03/04/2019
Supplement Date Received by Manufacturer03/04/2019
Initial Report FDA Received Date03/27/2019
Supplement Report FDA Received Date06/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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