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

Catalog Number 71303200

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 03/25/2009

Event Type  Injury  

Event Description

It was reported that patient had a dislocated hip.

Manufacturer Narrative

The associated reflection 3 hole shell, reflection liner, anthology ps high offset stem and cobalt chrome femoral head were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Consequently, the review of manufacturing records and complaint history 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 product failed to meet any product specifications at the time of manufacture.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis noted that based on the study information this was not revised but just reduced.The patient has since died 4 years later and there is no indication that this was related to the smith and nephew devices or the dislocations 4 years prior.No clinical relevant information has been provided for inclusion in this investigation.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, 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: 8483245
• MDR Text Key: 140921037
• Report Number: 1020279-2019-01381
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: K932755
• 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,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2018
• Device Catalogue Number: 71303200
• Device Lot Number: 08GM07838
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention