MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number 71335562

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problems Pain (1994); Injury (2348); Joint Disorder (2373)

Event Date 08/03/2015

Event Type  Injury  

Event Description

It was reported a right hip revision surgery was performed due to loosening of the acetabular shell and pain in the groin.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.

Manufacturer Narrative

This investigation has been re-opened and a supplemental mdr will be submitted at the conclusion of the investigation.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.(b)(4).

Event Description

It was reported that, after a right tha on (b)(6) 2013 patient presented pain and acetabular loosening.Patient underwent a revision surgery on (b)(6) 2015.Patient outcome is unknown.

• Brand Name: R3 3 HOLE ACET SHELL 62MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• 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 ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6237075
• MDR Text Key: 64346012
• Report Number: 1020279-2017-00021
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN FEMORAL HEAD; UNKNOWN LINER; UNKNOWN STEM; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female