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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM -3; PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD

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SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM -3; PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD Back to Search Results
Model Number 71342803
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 09/10/2020
Event Type  Injury  
Event Description
It was reported that primary procedure was performed on (b)(6) 2015.Patient dislocated 2 months ago and the hip was relocated but three weeks ago patient dislocated again bending over pulling weeds.Revision surgery was performed and oxinium fem hd 12/14 28mm -3 and r3 20 deg +4 xlpe acet lnr 28mm x 46mm were explanted.
 
Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the root cause of the reported dislocations were most likely the lack of posterior hip precautions (status post recent hip dislocation with subsequent reduction) finally exacerbated when the patient was reportedly ¿bending over pulling weeds¿.No details were provided on the first dislocation; however, it would not be uncommon for the surrounding tissues to be disrupted and/or weakened following the first reported dislocation/reduction leading to a higher risk.The patient impact beyond the reported recurrent dislocation and subsequent revision procedure could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
OXINIUM FEM HD 12/14 28MM -3
Type of Device
PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10651605
MDR Text Key210501655
Report Number1020279-2020-05257
Device Sequence Number1
Product Code LZO
UDI-Device Identifier03596010474155
UDI-Public03596010474155
Combination Product (y/n)N
PMA/PMN Number
K021673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/14/2021
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 Date02/24/2019
Device Model Number71342803
Device Catalogue Number71342803
Device Lot Number08GM05593A
Initial Date Manufacturer Received 09/10/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received09/10/2021
Supplement Dates FDA Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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