MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM LT SZ 7; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71421017
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to correct patients discomforts.Surgeon determined this patient had a "lack of flexion" in his knee.
Additional Manufacturer Narrative
The associated legion ps high flexion insert and genesis ii oxinium femoral component were returned and evaluated.A lab analysis was performed on the devices and it noted the tibia insert showed anterior deformation adjacent to the central inserter feature, lock detail deformations, and scratches and gouges on the inferior surface.The femoral component showed scratches on the posterior condyle articular surfaces, bone and bone cements adhered to the inferior surfaces.The report concluded the exact cause of observed scratches, gouges, and deformations could not be determined from the investigation of the devices.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical investigation conducted during this investigation noted that no clinical relevant information has been provided to perform a thorough analysis of this issue.Based on the lab analysis/examination of the returned explanted components, the reasons for revision could not be determined.No further clinical assessment of this case is warranted at this time.A review of the manufacturing records for the insert did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did reveal additional complaints for this part.The lot number for the femoral component is unknown.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: GII OXIN P/S FEM LT SZ 7
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7667884
• Report Number: 1020279-2018-01270
• Device Sequence Number: 1050476
• Product Code: JWH
• UDI-Device Identifier: 03596010469236
• UDI-Public: 03596010469236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71421017
• Initial Date Received by Manufacturer: 06/17/2018
• Supplement Date Received by Manufacturer: 06/17/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 12/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR