MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMP SZ 6 LEFT; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71420106
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to femoral loosening and post periprosthetic fracture.Intramedullary nailing of left fractured distal femur was performed by dr (b)(6) at (b)(6) on (b)(6)2019.The post of the poly had been intentionally damaged during the femoral nailing, as to gain access to the im canal without removing the insert.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to femoral loosening and post periprosthetic fracture.The insert, the femoral component and the nail were removed.The affected genesis ii ps hi flex insert and genesis ii cobalt chrome ps femoral component , used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.A medical analysis indicated that the two provided x-rays post im nailing/pre-revision support the complaint of loosening and periprosthetic fracture in the presence of an im nail and left tka with a non-united distal femoral fracture and radiolucency noted under the femoral component anteriorly.However, the provided photo of explanted components does appear to show an ample amount of bone/cement adhered to the explanted femoral component and shows the ¿intentionally damaged¿ post on the insert.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.It was communicated that the patient suffered a traumatic injury/fall approximately 10 years post left tka.The reported traumatic fall was most likely contributing factor to the reported loosening and femoral fracture.Without the return of the actual product involved, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GEN II COCR PS NP FEMORAL COMP SZ 6 LEFT
• 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: 9580052
• Report Number: 1020279-2020-00206
• Device Sequence Number: 3080033
• Product Code: JWH
• UDI-Device Identifier: 03596010205971
• UDI-Public: 03596010205971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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 Model Number: 71420106
• Device Catalogue Number: 71420106
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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