MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 5-6 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71453284
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient got infected after having a tooth extracted.Dr.Performed a washout and a poly exchange.After removing the original poly insert and debriding soft tissue and washing out the knee, dr.Replaced the original poly with the same size and thickness of the same deep dished poly insert.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded it was reported that during a washout and poly exchange revision for a suspected hematogenous infection (c-279708), the revision insert was difficult to seat due to ¿damage from the retractor¿ upon insertion (c-280290), thus the surgeon had to subsequently open a 2nd implant for successful implantation.Per the product complaint form, ¿i don¿t believe there was a fault with the first insert, it was difficult to seat due to the exposure and access to the lateral side of the knee.¿ based on the limited information provided, no device failure occurred.The patient impact beyond the reported revision due to infection, post tooth extraction, could not be determined, as no delay or patient harm was reported.No further medical assessment is warranted at this time.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Infection is a potential complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: LGN XLPE DISHED ISRT SZ 5-6 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9510650
• Report Number: 1020279-2019-04556
• Device Sequence Number: 1542747
• Product Code: JWH
• UDI-Device Identifier: 00885556255643
• UDI-Public: 00885556255643
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2020

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 Model Number: 71453284
• Device Catalogue Number: 71453284
• Device Lot Number: 17BM00467
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1