MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421510
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a tka surgery, the patient experienced a gns ii porous p/s fem sz4 lt and a gns ii cmt tib size 3 left loosening.This adverse event led to a revision surgery performed on (b)(6) 2021 in which metalosis was observed and polyethylene showed very little signs of wear.In addition it was discovered that the native patella had worn on the trochlear groove of the femoral implant, releasing metal debris into the joint.The gns ii porous p/s fem sz4 lt, the gns ii cmt tib size 3 left and the gns ii cmt tib size 3 left were explanted in the revision surgery.The patient current health status is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the loosening was confirmed.The clinical/medical investigation concluded that, reportedly, the root cause was loosening, metallosis, femoral component wear, and metal debris due to the ¿native patella, had worn on the trochlear groove¿ of the femoral implant.The provided images appear to support the reported complaint.However, comparison images were not provided.The patient's current condition is unknown and the patient impact beyond the reported loosening ¿metallosis¿/metal debris/wear, and revision surgery could not be determined.Further patient impact could not be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.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 PS HI FLEX ISRT SZ 3-4 13
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12523449
• Report Number: 1020279-2021-07099
• Device Sequence Number: 19110819
• Product Code: JWH
• UDI-Device Identifier: 03596010492920
• UDI-Public: 03596010492920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421510
• Device Catalogue Number: 71421510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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; Other; Required Intervention