MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20DEG 36MM TRIAL56MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71367956
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.

• Brand Name: R3 20DEG 36MM TRIAL56MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9318648
• Report Number: 1020279-2019-04023
• Device Sequence Number: 14043568
• Product Code: JDG
• UDI-Device Identifier: 03596010599896
• UDI-Public: 03596010599896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2019

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 Number: 71367956
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1