MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331952

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 03/27/2020

Event Type  Injury  

Event Description

It was reported that patient had smith+nephew components since (b)(6)2019.Revision surgery was performed on (b)(6) 2020 due to instability and chronic dislocation from the radicle tissue debridement.The cup, liner, screw and femoral head were removed.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9979777
• MDR Text Key: 188314989
• Report Number: 1020279-2020-01327
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 71331952
• Device Lot Number: 19AM05186
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71332525 REF SPHER HEAD SCREW 25MM.
• Patient Outcome(s): Hospitalization; Required Intervention