MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 11MM; PRSTHSIS,KNEE,PATLLFMRTIBIAL,SMI-CNSTRAIND,CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420818
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery poly would not stay locked in tibia, tried several times then opened another poly and it locked and stayed in.
Additional Manufacturer Narrative
The associated complaint device was not returned.Should information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: GII PS INSERT SZ 3-4 11MM
• Common Device Name: PRSTHSIS,KNEE,PATLLFMRTIBIAL,SMI-CNSTRAIND,CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7640017
• Report Number: 1020279-2018-01212
• Device Sequence Number: 19381998
• Product Code: JWH
• UDI-Device Identifier: 03596010209580
• UDI-Public: 03596010209580
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• 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): 09/12/2018

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: 71420818
• Device Lot Number: 17LT96065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1