MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 16MM X 160MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71424049
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection which includes removing all implants and inserting an antibiotic spacer.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no medical documents were received for investigation.Therefore no medical assessment can be performed.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.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the time.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.
Additional Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.The lab analysis concluded, the components showed evidence of burnishing, wear, and material deformation.The offset coupler and pressfit stem assembly show scratches, material deformation and residue on the stem.The tibial base shows scratches, wear, and material deformation.Bone residue was present on a majority of the distal surface.The femoral assembly shows scratches and wear on all components with bone cement residue remaining on the cemented side of the femoral component and femoral wedge.There is deformation and a deep groove on the tibial insert shown.Scratches, material deformation, and wear was also observed on the link, post bushing, axle bushing, sleeve, bolt, and axle.The observed damages could have been caused in vivo or during explantation.No material or manufacturing deviations were observed in the process of this investigation.The clinical/medical team concluded, this complaint was re-opened, however, no new relevant clinical information has been provided.No further clinical/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 parts revealed no prior complaints for the listed batches.Infection is a potential complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.Product was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: LGN PRESSFIT STEM 16MM X 160MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8044082
• Report Number: 1020279-2018-02403
• Device Sequence Number: 1463830
• Product Code: JWH
• UDI-Device Identifier: 03596010546814
• UDI-Public: 03596010546814
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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: 05/21/2022
• Device Model Number: 71424049
• Device Catalogue Number: 71424049
• Device Lot Number: 12EAB0005A
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 02/25/2020
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 04/14/2019; 03/03/2020
• 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