MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS PS FEM SZ 4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a tka surgery, the patient experienced tibial collapse and femur loosening due to an infection this adverse event led to a revision surgery in which three (3) components, a gii nonporous ps fem sz 4 rt, a gns ii cmt tib size 3 right and a lgn ps high flex xlpe sz 3-4 11mm were explanted.The current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the patient underwent a revision tka during which the femoral, tibial and insert were explanted.It was reported that the patient experienced tibial collapse and suspected femoral loosening due to an infection approximately 3 years post implantation.The anz complaint form indicated the surgeon did not blame the implants, the revision procedure went ¿perfect¿ and the surgeon was ¿happy¿ with the outcome.It was communicated that the primary tka date is unknown and no further medical documentation/information was available for inclusion in the medical investigation.Without the requested clinical documentation, the root cause of the reported event could not be fully assessed or concluded; however, the revision was reportedly due to tibial collapse and possible femoral loosening secondary to infection.The source of infection remains unknown.The patient impact beyond the reported symptoms secondary to infection and revision could not be determined.No further medical investigation could be rendered at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may 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 are 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: GII NONPOROUS PS FEM SZ 4 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12550930
• Report Number: 1020279-2021-07337
• Device Sequence Number: 5169364
• Product Code: JWH
• UDI-Device Identifier: 03596010206039
• UDI-Public: 03596010206039
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 71420118
• Device Catalogue Number: 71420118
• Device Lot Number: 19FM18689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown