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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20DEG 36MM TRIAL56MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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SMITH & NEPHEW, INC. R3 20DEG 36MM TRIAL56MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Back to Search Results
Catalog Number 71367956
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
It was reported that during a thr procedure, the sharp edges of the trial cut the gloves of the surgeon.Plastic liner had gouges.No delay.Backup device available.No impact or injury reported.
 
Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection confirms the trial has multiple scratches, burrs and deep gouges in the plastic.The device shows extreme signs of wear/usage.There is no lot number available for this device.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.
 
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Brand Name
R3 20DEG 36MM TRIAL56MM
Type of Device
PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9318648
MDR Text Key166824680
Report Number1020279-2019-04023
Device Sequence Number1
Product Code JDG
UDI-Device Identifier03596010599896
UDI-Public03596010599896
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71367956
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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