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

Catalog Number 71338664

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/26/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.

Manufacturer Narrative

The affected r3 multi hole acetabular shell, oxinium head and anthology porous plus standard offset stem were not returned for evaluation.A clinical evaluation noted that no clinical relevant documents will be provided to conduct a thorough medical assessment.Therefore, no medical assessment is warranted at this time.The impact to the patient beyond the revision cannot be concluded.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.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.

Manufacturer Narrative

Expiration date is corrected information.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7805865
• MDR Text Key: 117892385
• Report Number: 1020279-2018-01580
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556020630
• UDI-Public: 00885556020630
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71338664
• Device Lot Number: 16GW00776
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention