MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 ACETABULAR LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71331098

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: mw5117910.

• Brand Name: R3 ACETABULAR LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 17010662
• MDR Text Key: 316152882
• Report Number: MW5117909
• 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
• Report Date: 05/25/2023

1 Device was Involved in the Event

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: 71331098
• Device Catalogue Number: 71331098
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male