MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 11MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71420832
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to infection.The entire system was replaced.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.Only the tibial insert was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage and wear from implantation and extraction.The device was manufactured in 2007.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation of the revision due a reported infection cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Infection is a complication that can be associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.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.

• Brand Name: GII PS INSERT SZ 5-6 11MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9856832
• Report Number: 1020279-2020-00936
• Device Sequence Number: 2533393
• Product Code: JWH
• UDI-Device Identifier: 03596010209658
• UDI-Public: 03596010209658
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 06/20/2017
• Device Model Number: 71420832
• Device Catalogue Number: 71420832
• Device Lot Number: 07FM18492
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/12/2020
• 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