MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEM OR UNCEM

Catalog Number 71335548

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/23/2017

Event Type  Injury  

Event Description

It was reported that patient underwent a revision surgery to replace the acetabular cup which had twisted.It was also reported that according to the op report the cup has been good implanted and had stability.

• Brand Name: R3 3 HOLE ACET SHELL MM48
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEM OR UNCEM
• 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: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6484792
• MDR Text Key: 72502112
• Report Number: 1020279-2017-00256
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598226
• UDI-Public: 03596010598226
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P030022/S008
• 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
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2022
• Device Catalogue Number: 71335548
• Device Lot Number: 12BM03139
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 80