MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ7-8 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	71420552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a revision surgery took place on (b)(6) 2021 due to a luxated inlay.Primary surgery took place on (b)(6) 2020.The gns ii con ins sz7-8 11mm was exchanged.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms heavy damage to the locking detail due to the removing of the explant.The visual also confirms wear of the condyle on the insert and there is discoloration on the insert.A medical investigation was conducted and confirms this case reports a revision/poly exchange was performed due to luxation.A single x-ray was provided, however, the image provided is not of sufficient quality to make an assessment.To date, the requested medical/surgical records have not been provided.Without sufficient supporting medical evidence, the reported event cannot be thoroughly assessed, and a medical assessment cannot be rendered.Should medical/clinical records be provided, the clinical task can be re-evaluated and assessed at that time.A review of complaint history did not reveal additional complaints for the listed batch.A review of complaint history did not reveal additional complaints for the listed batch.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 risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II CON INS SZ7-8 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11611971
• Report Number: 1020279-2021-02638
• Device Sequence Number: 14224557
• Product Code: JWH
• UDI-Device Identifier: 03596010208187
• UDI-Public: 03596010208187
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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 Model Number: 71420552
• Device Catalogue Number: 71420552
• Device Lot Number: D1509312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 06/05/2021
• Initial Report FDA Received Date: 04/04/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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
• Patient Weight: 120