MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 13MM X 160MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71424046
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision surgery the constructed implants would not fit properly in patient.More than 30 minutes of delay was reported and backup device were available.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The tibia base, stem and coupler were assembled and had cement on the surfaces from the attempted implantation.The tibia insert had some minor scratches from attempted implantation.The cone had some scratches and debris in the porous surface from the attempted implantation.The devices were manufactured in 2014, 2017 and 2018.A dimensional inspection was attempted on the insert but it was too damaged from attempted use to obtain accurate measurements.The dimensional inspection of the tibial base and cone found them to be within specification.A review of complaint history did not reveal additional complaints for the listed batches.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.Some potential probable causes for this event could include an improper surgical technique or a fit/sizing issue.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PRESSFIT STEM 13MM X 160MM
• 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: 8597362
• Report Number: 1020279-2019-01837
• Device Sequence Number: 2293623
• Product Code: JWH
• UDI-Device Identifier: 03596010546784
• UDI-Public: 03596010546784
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71424046
• Device Catalogue Number: 71424046
• Device Lot Number: 17GAB0005D
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1