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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Model Number 71343604
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.
 
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.We consider this investigation closed.
 
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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 Key9311451
MDR Text Key166203033
Report Number1020279-2019-03958
Device Sequence Number1
Product Code JDH
UDI-Device Identifier03596010477286
UDI-Public03596010477286
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/13/2022
Device Model Number71343604
Device Catalogue Number71343604
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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