MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 15; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a (b)(6) year old male patient underwent a right total knee arthroscopy and a left total knee arthroscopy (rtka/ltka) poly exchange.Femoral implant size 7 on a tibal baseplate size 6 (7/6/15/35) was possible broken post after a fall.A revision surgery had to be performed on (b)(6) 2021 as genesis ii ps hi flex insert size 5-6 15 broke.As per report, patient twisted wrong and felt unstable, and upon a review of x-rays, it was noticed that the device post broke off.There were no implant records of exact date of original surgery, the resident just knew that it was in 2008.It is unclear which tibial insert was exchanged or if both were.No other complications were reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the as received tibial insert showed a fractured post with wear and deformation at the base of the post which remained on the tibial insert.The post tip was not received during the investigation.Wear, deformation, and scratching were observed on the articulating surface of the insert.The base of the post showed damage on the posterior surface.No material or manufacturing defects were observed in the component during investigation.The clinical/medical evaluation concluded that responses to documentation/information requests have not been received as of the date of this medical investigation.Reportedly, the patient underwent revision approximately 13 years post implantation for a ¿possible broken post after a fall¿.However, without the requested documentation, the clinical root cause of the reported event could not be fully assessed nor concluded.The patient impact beyond the reported fall and revision could not be determined.No further medical assessment could be rendered 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.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 risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.) based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 15
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11648440
• Report Number: 1020279-2021-02916
• Device Sequence Number: 11602032
• Product Code: JWH
• UDI-Device Identifier: 03596010492968
• UDI-Public: 03596010492968
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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 Expiration Date: 06/26/2018
• Device Model Number: 71421518
• Device Catalogue Number: 71421518
• Device Lot Number: 08FM12543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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; Other; Required Intervention