MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW BIRMINGHAM HIP RESURFACING FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Defective Component (2292)

Patient Problems Arrhythmia (1721); Emotional Changes (1831); Failure of Implant (1924)

Event Date 02/21/2023

Event Type  Injury  

Event Description

Pt presented to (b)(6) medical center on (b)(6) 2023 to have an implanted smith & nephew birmingham hip prosthesis removed stating he believes the metal on metal product has contributed to his other health comorbidities like his pacemaker, mood swings and arrythmias.Unknown date of implant at another hospital.Unable to determine if it is defective due to excessive amount of bioburden and tissue unable to be cleaned.Surgeon notes failed hardware, right hip.Surgery performed to remove was revision right total mako hip arthroplasty.

• Brand Name: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 16468485
• MDR Text Key: 310674392
• Report Number: MW5115380
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White