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

Model Number 71335756

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 06/21/2018

Event Type  Injury  

Event Description

Us legal: it was reported that a revision surgery was performed due to a emperion stem fracture.Intraoperatively it was found that the patient was infected, all the implants were removed and replaced with competitor devices.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, based on the limited information provided and without the return of the device for evaluation, the root cause of the reported stem fracture and infection cannot be determined but the reported corrosion is a possible contributor.The impact to the patient beyond the revision cannot be concluded.Should additional information become available, this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batches for the same failure modes.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the sterilization records revealed these batches were sterilized within normal parameters.Infection is a complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.Some potential probable causes of the device fracture could include overuse or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• 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: 9311448
• MDR Text Key: 166765763
• Report Number: 1020279-2019-03959
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 71335756
• Device Catalogue Number: 71335756
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention