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
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9975114
• Report Number: 1020279-2020-01321
• Device Sequence Number: 16688525
• Product Code: KTT
• UDI-Device Identifier: 03596010072863
• UDI-Public: 03596010072863
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 124126
• Device Catalogue Number: 121117
• Device Lot Number: 4A61783
• Initial Date Received by Manufacturer: 03/28/2020
• Supplement Date Received by Manufacturer: 02/25/2021; 10/05/2021
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 03/19/2021; 10/06/2021
• 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