MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS HIP SEMICONSTRAINED METALCERAMICCERAMICMETAL CEMENTED/UNCEMENTED

Catalog Number 71335550

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 10/03/2018

Event Type  Injury  

Event Description

It was reported that on revision the cup was found to be misaligned.No delay, injury or back reported.

Manufacturer Narrative

Updated device is considered the primary part for this event.

Manufacturer Narrative

The associated r3 3 hole acetabular shell, r3 0 deg xlpe acetabular liner and oxinium femoral head were not returned for evaluation.A clinical evaluation noted that no relevant supporting clinical information will be provided.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Our investigation including a review of the manufacturing records for the shell and the liner did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the shell revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• Type of Device: PROSTHESIS HIP SEMICONSTRAINED METALCERAMICCERAMICMETAL CEMENTED/UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8017280
• MDR Text Key: 125423772
• Report Number: 1020279-2018-02286
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: 71335550
• Device Lot Number: 09BM11090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 36650/17TM00723.; 71335550/09BM11090.
• Patient Outcome(s): Hospitalization; Required Intervention