MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 4 LT; PRSTHSS,KNEE,PTELLFMOROTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/POLYMER

Catalog Number	71423224
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to gonarthrosis.The devices were implanted in 2017 and explanted on (b)(6) 2018.
Additional Manufacturer Narrative
The associated genesis ii cmt tibial baseplate, legion ps femoral component and legion ps high flexion articular insert were not returned for evaluation.The devices were manufactured in 2017.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, based only on a partial translation of the handwritten note the mention of a ¿cement spacer¿ raise suspicion that the revision was performed due to infection.The patient impact beyond the reported revision cannot be determined and no further medical assessment is warranted at this time.Proper translation of the handwritten document has been requested.Should clinical information become available, the clinical/medical task may be re-opened.Products were sterilized according to sterilization release documentation from quality control.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated genesis ii cmt tibial baseplate, legion ps femoral component and legion ps high flexion articular insert were not returned for evaluation.The devices were manufactured in 2017.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, based only on a partial translation of the handwritten note the mention of a ¿cement spacer¿ raise suspicion that the revision was performed due to infection.The patient impact beyond the reported revision cannot be determined and no further medical assessment is warranted at this time.Proper translation of the handwritten document has been requested.Should clinical information become available, the clinical/medical task may be re-opened.Products were sterilized according to sterilization release documentation from quality control.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated genesis ii cmt tibial baseplate, legion ps femoral component and legion ps high flexion articular insert were not returned for evaluation.The devices were manufactured in 2017 and implanted in the same year.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.All devices were found to be sterilized according to sterilization release documentation from quality control.Complaint record review found no other complained devices for the reported condition.The revision procedure was identified to have taken place due to gonarthrosis.Gonarthrosis is a joint disease that can often develop in patients.As the disease progresses, however, pain in the knees intensifies and begins to significantly restrict a person¿s ability to move normally as they go about their daily activities.There were no indications that the explanted devices were considered at fault for the patient¿s condition.A clinical evaluation noted that no relevant documentation was provided, therefore, a thorough medical investigation could not be performed.The patient impact beyond the reported revision cannot be determined and no further medical assessment is warranted at this time.Should clinical information become available, the clinical/medical task will be reopened and reevaluated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional event information be received, the complaint will be reopened and reevaluated.

• Brand Name: LEGION PS NP FEM SZ 4 LT
• Common Device Name: PRSTHSS,KNEE,PTELLFMOROTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8446266
• Report Number: 1020279-2019-01152
• Device Sequence Number: 16229328
• Product Code: JWH
• UDI-Device Identifier: 00885556030349
• UDI-Public: 00885556030349
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2019

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: 71423224
• Device Lot Number: 17CM21130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 02/21/2019; 02/21/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/13/2019; 04/15/2019; 04/16/2019
• 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: Other; Required Intervention
• Patient Age: 44 YR