MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COMPRESSION HIP SCREW HEX HEAD COMPRESSING SCREW 28.5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 124126

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/06/2020

Event Type  Injury  

Event Description

It was reported that a plate was implanted in patients left hip due to a bone cyst in (b)(6) 2009.Patient had ongoing issues with pain over the years; however, pain intensified in 2019 to the point patient needed to be on crutches.She asked for two different medical opinions and found an orthopedic surgeon willing to take just the top screw which looked to be partially out.During the revision surgery, they found the screw wasn't even in, and they just needed to grab it out.

Event Description

It was reported that a plate was implanted in patients left hip due to a bone cyst in (b)(6) 2009.Patient had ongoing issues with pain over the years; however, pain intensified in 2019 to the point patient needed to be on crutches.She asked for two different medical opinions and found an orthopedic surgeon willing to take just the top screw which looked to be partially out.During the revision surgery, they found the compressing screw 28.5mm wasn't even in, and they just needed to grab it out.The patient continued to have pain in the left leg.A test done from orthopedic analysis shows that the patient is hypersensitive to nickel and chromium and further testing is going to be initiated.

• Brand Name: COMPRESSION HIP SCREW HEX HEAD COMPRESSING SCREW 28.5MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9975114
• MDR Text Key: 188138885
• Report Number: 1020279-2020-01321
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 03596010072863
• UDI-Public: 03596010072863
• Combination Product (y/n): N
• PMA/PMN Number: K954712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 124126
• Device Catalogue Number: 121117
• Device Lot Number: 4A61783
• Initial Date Manufacturer Received: 03/28/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 02/25/2021; 10/05/2021
• Supplement Dates FDA Received: 03/19/2021; 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention