MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 9MM; PRSTHSSKNEEPTLLFMRTIBLSMICNSTRINDCMNTDPLYMRETALPOLYMR

Model Number	71453111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to revise the insert on (b)(6) 2020 due to pain.Primary surgery was performed on (b)(6) 2015.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily damaged from wear, insertion and extraction.The device was manufactured in 2015.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation could not be rendered.The root cause of the reported pain could not be assessed and the patient impact beyond the reported pain and insert revision approximately 4.5 years post implantation could not be determined.Should any additional clinical information be provided this complaint may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents was conducted.Pain is a potential complication associated with any surgery.Some potential probable causes could include patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 9MM
• Common Device Name: PRSTHSSKNEEPTLLFMRTIBLSMICNSTRINDCMNTDPLYMRETALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720208
• Report Number: 1020279-2020-00600
• Device Sequence Number: 2352797
• Product Code: JWH
• UDI-Device Identifier: 00885556033975
• UDI-Public: 00885556033975
• Combination Product (Y/N): N
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 05/29/2025
• Device Model Number: 71453111
• Device Catalogue Number: 71453111
• Device Lot Number: 15FM00216
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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