MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335754

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374); No Information (3190)

Event Date 12/09/2016

Event Type  Injury  

Event Description

It was reported to use that the patient underwent a revision surgery with change of the r3 insert and the ball head due to dislocation of the insert.The total hip replacement is a combination of polarstem/r3 acetabular shell.

Manufacturer Narrative

A correction based on new information produced.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6295907
• MDR Text Key: 66333481
• Report Number: 1020279-2017-00078
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335754
• Device Lot Number: 15HM14296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: POLARSTEM FEMORAL STEM, PART&LOT#UNKNOWN; R3 ACETABULAR SHELL, PART&LOT#UNKNOWN; UNKNOWN FEMORAL BALL HEAD, PART&LOT#UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72