MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71928109

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 04/27/2010

Event Type  Injury  

Event Description

A revision surgery was performed due to loosening.Acetabular cup was revised.

Manufacturer Narrative

The associated reflection ceramic cup and 36mm delta liner were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts 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 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 evaluation noted the x-ray provided shows a cup with two screws and some radiolucency medially which could be an osteolytic cyst but the revision op report was not provided to confirm.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported loosening cannot be determined.The impact to the patient beyond the revision cannot be concluded.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Without the return of the actual products 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 devices or additional information be received, the complaint will be reopened.

• Brand Name: HIP IMPLANT
• 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: 8480067
• MDR Text Key: 140820265
• Report Number: 1020279-2019-01365
• 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,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2018
• Device Catalogue Number: 71928109
• Device Lot Number: 08CM00581A
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NUMBER 71357108 / LOT NUMBER 07JM16105AH; UNKNOWN FEMORAL HEAD COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR