MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM; PLATE, FIXATION, BONE

Catalog Number	72585216
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery was performed, the locking screws started to back out of the locking holes on the evos 3.5/4.5 pp dis fem pl r 16h 333mm.No intervention has been done yet; however, the surgeon is planning a revision surgery.There is no further information available.
Additional Manufacturer Narrative
H11: corrected data: updated section b2, b5, d9 and h3.
Event or Problem Description
It was reported that, after an internal fixation surgery was performed, the locking screws started to back out of the locking holes on the evos 3.5/4.5 pp dis fem pl r 16h 333mm.A revision surgery was performed on an unknown date to solve the adverse event.

• Brand Name: EVOS 3.5/4.5 PP DIS FEM PL R 16H 333MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17977172
• Report Number: 1020279-2023-02001
• Device Sequence Number: 11642753
• Product Code: HRS
• UDI-Device Identifier: 00885556771112
• UDI-Public: 885556771112
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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 Catalogue Number: 72585216
• Device Lot Number: 22HM14738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 07/10/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/15/2023; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVOS 4.5MM X 38MM CTX SCR S-T; EVOS 4.5MM X 42MM CTX SCR S-T; EVOS 4.5MM X 46MM CTX SCR S-T; EVOS 4.5MM X 70MM LCK SCR S-T; EVOS 4.5MM X 76MM LCK SCR S-T; EVOS 4.5MM X 76MM LCK SCR S-T; EVOS 4.5MM X 80MM LCK SCR S-T; EVOS 4.5MM X 85MM LCK SCR S-T
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown