MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 18; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	71421518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to exchange genesis ii ps hi flex insert size 5-6 18.The reason for the revision surgery is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, an insert revision was performed due to an unknown reason after an unknown length of time in-vivo.Based on the limited information provided, the root cause could not be concluded.No surgical delay or patient injury was reported.The patient impact beyond the reported insert revision could not be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 18
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10604405
• Report Number: 1020279-2020-04950
• Device Sequence Number: 16879180
• Product Code: JWH
• UDI-Device Identifier: 03596010492968
• UDI-Public: 03596010492968
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: Lay User/Patient
• Device Model Number: 71421518
• Device Catalogue Number: 71421519
• Device Lot Number: 17CM20646
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 06/26/2021
• 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