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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIAL 20 DEG 28MM 50-52 OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. TRIAL 20 DEG 28MM 50-52 OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71362850
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a thr a excessive torque was applied on screw in portion of trial liner, screw in portion snapped off.No injuries or delays reported.S&n back up available.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints 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 28MM 50-52 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 Key8427372
Report Number1020279-2019-01080
Device Sequence Number2639748
Product Code JDI
UDI-Device Identifier03596010455307
UDI-Public03596010455307
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 company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/19/2019
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 Number71362850
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/15/2019
Supplement Date Received by Manufacturer02/15/2019
Initial Report FDA Received Date03/17/2019
Supplement Report FDA Received Date06/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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