MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 13; PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER

Model Number	71421517
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that genesis ii ps hi flex insert size 5-6 13 post broke off inside of the patient 7 years after implantation.Revision surgery was performed but no information about this procedure was initially provided.
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, per the complaint details, a revision was performed due to a gii ¿poly post broke off¿ approximately 7 years post implantation.S+n has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event; however, no injury was reported.The patient impact beyond the reported post breakage and revision could not be determined.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.No further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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 PS HI FLEX ISRT SZ 5-6 13
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10463942
• Report Number: 1020279-2020-04271
• Device Sequence Number: 2553223
• Product Code: JWH
• UDI-Device Identifier: 03596010492951
• UDI-Public: 03596010492951
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 71421517
• Device Catalogue Number: 71421517
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/27/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 06/28/2021
• 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