MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. STEM

Model Number 71356108

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 09/19/2023

Event Type  Injury  

Event Description

Presents to hospital after acute inability to ambulate on his right lower extremity.Patient further explained that on the day prior to presentation he was walking across his kitchen when he felt a snap and all of a sudden his right lower extremity collapsed from under him and was unable to bear weight afterwards.Event was completely atraumatic.Patient initially presented to an outside hospital and was noted to have failure of his right femoral implant.Patient transferred to ummc and on (b)(6)2021 underwent a revision, right total arthroplasty, hip.Femoral head explanted at 1715 description: imp head femoral snn bipolar cobalt 36mm +12 ref:(b)(4), lot: 19jm2304, expiration date: 9/27/2029, date implanted (b)(6) 2019.Stem explanted at 1800 imp stem snn high offset sz 8, ref: (b)(4), lot 13lm08143, expiration date: 11/30/2023, date implanted: (b)(6)2014.

• Brand Name: STEM
• Type of Device: STEM
• Manufacturer (Section D): SMITH AND NEPHEW, INC.
• MDR Report Key: 17985385
• MDR Text Key: 327279110
• Report Number: 17985385
• Device Sequence Number: 2
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 71356108
• Device Catalogue Number: 71356108
• Device Lot Number: 13LM08143
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White