MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453234
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pt.Had tka (b)(6) 2013.Jumped off of fence sheared the post.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no clinically relevant or supporting documentation was provided, therefore a thorough medical investigation could not be performed.However, per the complaint details, the post broke upon blunt force trauma/jumping off fence.The patient impact beyond probable pain, the revision surgery itself, and an expected post-op rehabilitation phase cannot be determined.No further medical assessment is warranted at this time.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.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: LGN PS HIGH FLEX XLPE SZ 7-8 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis 38116
• MDR Report Key: 7970314
• Report Number: 1020279-2018-02196
• Device Sequence Number: 1214586
• Product Code: JWH
• UDI-Device Identifier: 00885556034507
• UDI-Public: 00885556034507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 11/09/2020
• Device Catalogue Number: 71453234
• Device Lot Number: 10LM09169
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention