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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Model Number 74120158
Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Injury (2348); Test Result (2695)
Event Date 08/26/2010
Event Type  Injury  
Event Description
Concerning to left hip, implanted (b)(6) 2008.Excessive metal levels in the blood mades necessary to undergo revision surgery.It is not confirmed whether a revision surgery has taken place.Aspiration under anesthesia on left hip has been performed.
 
Manufacturer Narrative
Correction aware date: pma/510k: (b)(6)2019.
 
Manufacturer Narrative
An irish legal claim was received, stating that a patient was requesting revision surgery due to elevated ion levels.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 cup, head & sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the known 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 a result of the reported event.The available medical documents were reviewed.The reported findings of elevated metal ion levels may be consistent with findings associated with metal debris.The root cause of the reported symptoms noted in this legal claim cannot be confirmed, as the x-ray reports revealed the implant remained in satisfactory position and alignment with no evidence of loosening, and the surgeon¿s statement that he would be very reluctant to offer him revision surgery on the basis of the current findings.It cannot be concluded that the reported reactions/events were associated with a malperformance of the implant.It is unknown to date whether a revision surgery has taken place.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
ACETLR CUP HAP 58MM W/ IMPTR
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key9391991
MDR Text Key168580566
Report Number3005975929-2019-00421
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010502605
UDI-Public03596010502605
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2013
Device Model Number74120158
Device Catalogue Number74120158
Device Lot Number088776
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/01/2019
Initial Date FDA Received11/29/2019
Supplement Dates Manufacturer Received11/01/2019
11/01/2019
Supplement Dates FDA Received11/29/2019
04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODULAR HEAD 50MM 74222150/08GW17718; MODULAR SLEEVE 74222100/08FW17504
Patient Outcome(s) Hospitalization; Required Intervention;
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