MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MODULAR FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71342344

Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Metal Related Pathology (4530)

Event Date 04/26/2013

Event Type  Injury  

Event Description

Reporter calling, stating that a recalled hip was implanted in him and caused numerous injuries.He states that after receiving a hip implant, the hip "subsided, dislocated" and that he also suffered from a fractured femur, infection, and "was treated for metallosis".He states the device loosened and also caused problems in the area of his lumbar spine and all this required a revision procedure.Reporter states he learned the hip was recalled however it was still "sold to my doctor one year after" the recall.Reporter states that he is upset that a recalled device was allowed to be sold and implanted in him.He states he has contacted smith & nephew regarding this matter and also states that the fda should "investigate this company for engaging in illegal practices".Reference report: mw5117909.

Event Description

Additional information received from reporter on 20-nov-2023, for mw5117910.Reporter calling with updated device information.Reporter additionally states that his concerns is that his implanted hip "did not have 510(k) clearance at the time of implant." reporter states he believes a "fraudulent" hip was implanted.Reporter states he has the operative report from "(b)(6) hospital" and the report has "no serial number, and no lot number.".

• Brand Name: MODULAR FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 17010677
• MDR Text Key: 316153285
• Report Number: MW5117910
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 71342344
• Device Catalogue Number: 71342344
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male