MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 7-8 9MM; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR

Model Number	71453257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed nine years after primary surgery due to the post from the legion xlpe ps insert size 7-8 9mm broke.The reason for the breakage is not known.

• Brand Name: LGN XLPE PS INSERT SZ 7-8 9MM
• Common Device Name: PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9857494
• Report Number: 1020279-2020-00943
• Device Sequence Number: 2533397
• Product Code: JWH
• UDI-Device Identifier: 00885556255803
• UDI-Public: 00885556255803
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2021
• Device Model Number: 71453257
• Device Catalogue Number: 71453257
• Device Lot Number: 11BM05228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR