MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331752

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/30/2015

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized due to leg pain.This was treated via nerve root block (injection).

Manufacturer Narrative

It was reported that the patient was hospitalized due to leg pain.The affected r3 delta ceramic liner, biolox delta head, r3 acetabular shell and synergy porous plus high offset stem, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis noted there was no septic etiology reported and this adverse event was treated via nerve root block (injection).No revision surgery has been scheduled or performed yet.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but not limited to traumatic injury, patient reaction or joint tightness.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 36MM ID INTL DLT CER LNR 52MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9446852
• MDR Text Key: 170127054
• Report Number: 1020279-2019-04360
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study,user facility
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 71331752
• Device Lot Number: 10ET42513
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention