MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMR, POROUS

Model Number 71338664

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 02/27/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to loosening.The r3 multi-hole acetabular shell 50mm was explanted.The patient is also complaining about pain and feeling strange.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMR, 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9828575
• MDR Text Key: 183250175
• Report Number: 1020279-2020-00858
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556020630
• UDI-Public: 00885556020630
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092386
• 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
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71338664
• Device Catalogue Number: 71338664
• Device Lot Number: 19JW12669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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): Required Intervention