MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 LEFT; PROSTH, KNEE, PATELLFEMTIBIAL, SEMI-CONSTR, CEMENTED, POLY/METAL/POLY

Model Number	71420170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a recon surgery had been performed, the patient reported an infection.The adverse event was addressed with a revision surgery on (b)(6) 2021 to replace the lgn cr high flex xlpe sz 5-6 10mm, gii lng stem 10mm x 100mm, gns ii cmt tib size 6 left, legion cr np fem sz 6 lt, and gns ii resurf pat 35mm.The condition of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the requested operative reports are not available for review.Without the requested clinical information, a thorough medical investigation cannot be rendered.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.It was also communicated via the customer feedback form the surgeon does not blame device and is happy with the surgical outcome.Should any additional clinical information be provided this complaint will be re-evaluated.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.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.Without the return of the actual product involved, our investigation could not proceed.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 LEFT
• Common Device Name: PROSTH, KNEE, PATELLFEMTIBIAL, SEMI-CONSTR, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11845709
• Report Number: 1020279-2021-04399
• Device Sequence Number: 4016926
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 08/27/2021

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: 71420170
• Device Catalogue Number: 71420170
• Device Lot Number: H1808892
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention