MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71453173
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient reported that the tkr has fail.She has fall several times and it was confirmed by surgeon a surgery must be performed.The doctor thinks the insert should be replaced, awaiting on confirmation from another surgeon.Revision surgery has not been scheduled yet.
Event or Problem Description
As updated, revision surgery scheduled for (b)(6) 2018.Doctor thinks the insert needs to be a bigger size.
Additional Manufacturer Narrative
The associated devices were not returned for evaluation, as they remain implanted.No clinically relevant supporting documentation has been provided at the time of this review, therefore a thorough medical assessment cannot be performed.A review of manufacturing records did not reveal any abnormalities that could have contributed to the reported issue.A review of complaint history revealed that we have not had any previous complaints for the listed batches/failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 10MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7349617
• Report Number: 1020279-2018-00330
• Device Sequence Number: 679700
• Product Code: JWH
• UDI-Device Identifier: 00885556486948
• UDI-Public: 00885556486948
• 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 Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2018

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 Catalogue Number: 71453173
• Device Lot Number: 16LM12225
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 03/01/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 05/02/2018; 06/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68