MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM LEFT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the patient presented to the hospital with a psychiatric illness.During the evaluation, the left knee and left leg were found to be swollen and painful proximally.The left knee was aspirated and found to have visible pus, so the patient was booked for revision of the first stage of the left knee arthroplasty and removal of all hardware.A revision surgery was performed to remove all prostheses and insert an antibiotic spacer.After removal of the prosthesis, pus was visualized in the tibial and femoral canals, lavage was performed, and a spacer was inserted.
Additional Manufacturer Narrative
It was reported that the patient presented to the hospital a few days ago with a psychiatric illness.During the evaluation the left knee and left leg were found to be swollen and painful proximally.The left knee was aspirated and found to have visible pus, so the patient was booked for revision of the first stage of the left knee arthroplasty and removal of all hardware.Revision surgery was performed to remove all prostheses and insert an antibiotic spacer.After removal of the prosthesis, pus was visualized in the tibial and femoral canals, lavage was performed, and a spacer was inserted.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes 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.A review of the complaint history for the listed part revealed no prior complaints for the listed batch with the same failure mode.The device was sterilized according to sterilization release documentation from quality control.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A medical analysis noted that the provided unidentified/undated left tka x-ray image was reviewed; however, it does not provide insight into the root cause of the reported event.Per the report, no implantation data could be provided regarding the femoral medial and lateral plates/screws noted on x-ray proximal of the left tka components.It was communicated that the requested medical documentation was not available due to lack of consent.The provided intra-op photos of explanted components were reviewed, but also did not aid in the medical investigation.No further clinically relevant documentation was provided.Based on information provided, the revision was due to the reported purulent infection; however, the source of infection could not be concluded.The patient impact beyond the reported symptoms and subsequent first-stage revision could not be determined, although a second-stage procedure would be anticipated.No further medical assessment could be rendered at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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.

• Brand Name: GII OXIN P/S FEM LEFT SZ 6
• 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: 11167461
• Report Number: 1020279-2021-00356
• Device Sequence Number: 3111273
• Product Code: JWH
• UDI-Device Identifier: 03596010469229
• UDI-Public: 03596010469229
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2026
• Device Model Number: 71421016
• Device Catalogue Number: 71421016
• Device Lot Number: 16CM07629
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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; Required Intervention