MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 64MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331964

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 08/09/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to a patient suffering from a dislocated hip.The patient hyperextended.The shell was removed, reamed and trialled and new shell implanted.

Manufacturer Narrative

It was reported that revision surgery was performed due to a patient suffering from a dislocated hip.The patient hyperextended.The shell was removed, reamed and trialed and new shell implanted.The affected r3 three hole hemisperical shell, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.According to the risk management file, possible causes could include but not limited to cup mis-alignment or patient anatomy.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No root cause can be determined at this time.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 64MM
• 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: 8958227
• MDR Text Key: 156388357
• Report Number: 1020279-2019-03255
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331964
• Device Lot Number: 17JM06275
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention