MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC ACF EXT ROT PAD RT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71441252
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a malfunction in which the surgeon was taking the paddles off the femur and the center screw in the middle came out.
Additional Manufacturer Narrative
The affected device was returned and evaluated.A visual inspection confirmed the complaint that the gii rotation paddles' spring plunger has disassembled.The device was manufactured in 2010 and exhibits signs of wear and use.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit has been issued for this device.

• Brand Name: GII SPC ACF EXT ROT PAD RT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7734966
• Report Number: 1020279-2018-01445
• Device Sequence Number: 11456024
• Product Code: MBH
• UDI-Device Identifier: 00885556034767
• UDI-Public: 00885556034767
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• 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): 07/23/2018

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: 71441252
• Device Lot Number: 10DM03847
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1