MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71338554

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/06/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to unknown reasons.

Manufacturer Narrative

The associated r3 mutliple hole acetabular shell, r3 20 deg acetabular liner and reflection spherical head screws were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed parts with the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Without the return of the actual product involved, our investigation of this report is inconclusive.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM
• 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: 8130578
• MDR Text Key: 129248472
• Report Number: 1020279-2018-02677
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71338554
• Device Lot Number: 16CM19011
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention