MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420188
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a tkr washing, at the time of opening the patient, there was a large amounts of pus present, so the tkr implants were removed due to infection and cement spacer was inserted.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information: a3.H3, h6: the device, intended for use in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical / medical investigation concluded that, this case reports that a tkr washout procedure was planned, however when the patient was opened up, there was large amounts of pus present.Therefore, due to infection, all of the tkr implants were removed and an antibiotic spacer was inserted.Per email communication, the requested surgical reports will not be provided.A single undated x-ray was provided, however it does not provide a clinical root cause for the infection.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of the 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 the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.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.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical / medical investigation concluded that, this case reports that a tkr washout procedure was planned, however when the patient was opened up, there was large amounts of pus present.Therefore, due to infection, all of the tkr implants were removed and an antibiotic spacer was inserted.Per email communication, the requested surgical reports will not be provided.A single undated x-ray was provided, however it does not provide a clinical root cause for the infection.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of the 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 the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.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: GNS II CMT TIB SIZE 6 RIGHT
• 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: 11042027
• Report Number: 1020279-2020-07593
• Device Sequence Number: 16817295
• Product Code: JWH
• UDI-Device Identifier: 03596010206367
• UDI-Public: 03596010206367
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 71420188
• Device Catalogue Number: 71420188
• Device Lot Number: J1803883
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 08/11/2021; 08/31/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 08/12/2021; 09/01/2021
• 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: Required Intervention