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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #12 IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #12 IMPLANT Back to Search Results
Catalog Number 6052-1240S
Device Problems Device Operates Differently Than Expected; Insufficient Information
Event Date 08/18/2015
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information was requested and if it becomes available will be submitted in a supplemental report. Patient elected to keep.

 
Event Description

Patient's hip was revised for femoral pain and leg length deficiency. Femoral stem was replaced with rest mod stem and mdm head.

 
Manufacturer Narrative

An event regarding limb length discrepancy involving a securfit stem was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as no device was returned for investigation. -medical records received and evaluation: not performed as no patient medical records were provided for review. -device history review: all devices accepted into final stock conformed to specification. -complaint history review: there have been no similar previous reported events for this lot id. Conclusions: the exact cause of the event could not be determined because no patient medical records were provided for review and the device was not returned for investigation. No further investigation for this event is possible at this time. If devices and/or additional information become available, this investigation will be reopened.

 
Event Description

Patient's hip was revised for femoral pain and leg length deficiency. Femoral stem was replaced with rest mod stem and mdm head.

 
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Brand NameSECUR-FIT MAX 127 HIP STEM #12
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key5077097
Report Number0002249697-2015-03007
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device Catalogue Number6052-1240S
Device LOT NumberMND0HW
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/15/2015 Patient Sequence Number: 1
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