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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; FEMORAL BROACH
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CORIN MEDICAL METAFIX; FEMORAL BROACH Back to Search Results
Model Number 340.434H
Device Problems Patient-Device Incompatibility (2682); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
Per -(b)(4) initial report: additional information, including the return of the reported broaches, the broach part nos.And lot codes, operative notes, length of surgical delay, post primary x-rays and a detailed patient outcome following the surgery was requested in order to progress with the investigation of this event; however, not all has been provided and thus there is only very limited information available for the investigation.The appropriate device details for the reported broaches have now been provided and the relevant device manufacturing records will be identified and reviewed.Post primary x-rays have also been provided and will be reviewed at corin.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa; however, this event occurred outside of the usa.
 
Event Description
It was reported that the metafix h broaches did not reach the required depth.Impact of the original implant did not reach the desired depth and following four attempts, the stem and head were changed.The patient ended up with a +7mm leg length discrepancy.
 
Manufacturer Narrative
Per -1896 final report.Additional information, including the return of the devices, the broach part no.And lot code, operative notes, length of surgical delay, post primary and pre revision x-rays and a detailed patient outcome was requested in order to progress with the investigation of this event, however, not all could be provided and thus the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Additionally the reported broach and stem were returned to corin, measured and found to be of correct specification.Based on this, there is no product design / manufacture conclusion that can be made.It is a known complication that certain patient anatomies may present challenges in seating stems and ofter surgeons will need to distal ream.Therefore, corin now considers this case closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
It was reported that the metafix h broaches did not reach the required depth.Impact of the original impalction did not reach the desired depth and following four attempts the head and stem were changed.The patient ended up with a +7mm leg length discrepancy.
 
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Brand Name
METAFIX
Type of Device
FEMORAL BROACH
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester
gloucestershire, GL7 1 YJ
UK  GL7 1YJ
MDR Report Key8431758
MDR Text Key139175725
Report Number9614209-2019-00018
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K082525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number340.434H
Device Catalogue NumberNOT APPLICABLE
Device Lot Number303211-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Date Manufacturer Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BIOLOX CERAMIC HEAD - 104.3600, 406916; BIOLOX CERAMIC HEAD - 104.3600, 406916; METAFIX BROACH - 340.470, 285842-05; METAFIX BROACH - 340.470, 285842-05; METAFIX BROACH - 340.471, 285845-02; METAFIX BROACH - 340.471, 285845-02; METAFIX BROACH - 340.472, 285850-02; METAFIX BROACH - 340.472, 285850-02; METAFIX STEM - 579.2004, 389295; METAFIX STEM - 579.2004, 389295; BIOLOX CERAMIC HEAD - 104.3600, 406916; METAFIX BROACH - 340.470, 285842-05; METAFIX BROACH - 340.471, 285845-02; METAFIX BROACH - 340.472, 285850-02; METAFIX STEM - 579.2004, 389295
Patient Outcome(s) Hospitalization; Required Intervention;
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