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 Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 10/22/2018

Event Type  Injury  

Event Description

It was reported that, after two dislocation episodes (one getting out of low recliner and the second bent over with leg flexed to reach foot), a revision surgery was performed to change femoral head and liner to a constrained liner.

Manufacturer Narrative

The associated biolox delta head and r3 delta ceramic liner were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed parts including the ring 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.However, the supplier of the devices will be informed about this issue.Our clinical evaluation noted that from one of the two undated x-ray photos, the reason for the dislocation cannot be concluded as the angle of inclination cannot be confirmed based on this image but it is not estimated to be extreme.Due to the dislocations a revision surgery was performed a little less than one month post op.The previous incision was used to open the joint, the joint was found stable.The information provided by the sales representative did not indicate a dislocation was observed during the revision.The head and liner were removed and appropriate size constrained liner and head were inserted.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported dislocations cannot be determined.No further clinical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reevaluated.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: 8063963
• MDR Text Key: 126917719
• Report Number: 1020279-2018-02441
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010566959
• UDI-Public: 03596010566959
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331752
• Device Lot Number: 17LT95066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NUMBER :76539165/LOT NUMBER :18DT02263; PART NUMBER :76539165/LOT NUMBER :18DT02263
• Patient Outcome(s): Other; Required Intervention