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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 71331952
Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Tissue Breakdown (2681); No Information (3190); Joint Laxity (4526)
Event Date 08/27/2013
Event Type  Injury  
Event Description
It was reported that, after a left tha surgery had been performed, the clinical subject experienced an unspecified adverse event related to metal-on-metal exposure.This issue was resolved by performing a revision surgery.An unspecified anthology size 8 stem, an unspecified size 40 metal femoral head, an unspecified size 40/52 metal liner, and an unspecified, uncemented size 52 acetabular shell were explanted.The patient outcome is unknown.
 
Event Description
It was reported that, after a left tha surgery had been performed, the clinical subject experienced an unspecified adverse event related to metal-on-metal exposure.This issue was resolved by performing a revision surgery.An unspecified anthology size 8 stem, an unspecified size 40 metal femoral head, an unspecified size 40/52 metal liner, and an unspecified, uncemented size 52 acetabular shell were explanted.The patient outcome is unknown.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
 
Manufacturer Narrative
It was reported from a clinical study that, after a left r3-tha construct had been implanted, the patient experienced pain, clicking, and a feeling that the hip would collapse, and was diagnosed with iliotibial band breakage and bursitis.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the device failed to meet specifications.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Potential causes of the reported event could include but are not limited to patient reaction or patient conditions.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
 
Event Description
[study: anthology r11006-1; subject id: ash055; ae#: unk] it was reported that, after a left r3-tha construct had been implanted, the clinical subject experienced pain, clicking, and a feeling that the hip would collapse, and was diagnosed with iliotibial band breakage and bursitis.This issue was resolved by performing a revision surgery.The patient outcome is unknown.
 
Manufacturer Narrative
It was reported through a clinical study that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 liner, r3 shell, modular head, modular sleeve and anthology stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the stem and shell.This will continue to be monitored.Similar complaints have been identified for the sleeve, liner and head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.Smith and nephew has not received the device or patient specific, adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
R3 3 HOLE HA CTD ACET SHELL 52MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd
memphis, tn TN 38116
MDR Report Key10103823
MDR Text Key193037124
Report Number1020279-2020-01927
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 02/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2019
Device Catalogue Number71331952
Device Lot Number09FM03005A
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
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