MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 7-8 9MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71453291
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when trying to implant, both of the final polys would not completely seat into the tibial tray, even though both locking mechanisms appeared to be in good condition.A delay greater than 30 minutes was reported due to this event.
Additional Manufacturer Narrative
The affected legion dished articular inserts were returned and evaluated.A visual inspection of the products found moderate damage on the locking detail feature.A dimensional inspection was attempted; the damage/deformation at several features of the devices would not allow for accurate measurement.The devices were manufactured in 2013.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN XLPE DISHED ISRT SZ 7-8 9MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8107855
• Report Number: 1020279-2018-02615
• Device Sequence Number: 19360853
• Product Code: JWH
• UDI-Device Identifier: 00885556255582
• UDI-Public: 00885556255582
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• 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): 03/18/2019

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 Expiration Date: 08/04/2023
• Device Catalogue Number: 71453291
• Device Lot Number: 13HM03683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1