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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ETS. HIP ENDOPROSTHESIS; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH ETS. HIP ENDOPROSTHESIS; IMPLANT Back to Search Results
Catalog Number 0590-3-047
Device Problem Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2014
Event Type  malfunction  
Event Description
The customer reported via the territory sales manager that when the stem was opened prior to implantation, the theatre staff noticed a scratch on the surface of the device.The customer did not specify the size or location of the scratch.The customer reported that a replacement device was immediately available to complete the surgery successfully with no adverse consequences or delays to surgery time.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.
 
Manufacturer Narrative
An event regarding damage involving an ets stem was reported.The event was confirmed.-device evaluation and results: the stem has not been used.Surface is polished.A scratch is visible at the end of the stem, at approximately 7mm from the distal point of the stem.No other scratch or mark is visible.A material analysis report concluded that the indication was a result of a foreign material, likely a plain medium carbon steel, being embedded into the surface of the hip stem during manufacture.-medical records received and evaluation: not performed as medical records were not received for evaluation.The device was not implanted.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: the root cause of this event is the result of a foreign material, likely a plain medium carbon steel, being embedded into the surface of the hip stem during manufacture.The ncr was raised to investigate the issue (root cause and corrective / preventative actions) and nc was raised to investigate the event.
 
Event Description
The customer reported via the territory sales manager that when the stem was opened prior to implantation, the theatre staff noticed a scratch on the surface of the device.The customer did not specify the size or location of the scratch.The customer reported that a replacement device was immediately available to complete the surgery successfully with no adverse consequences or delays to surgery time.
 
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Brand Name
ETS. HIP ENDOPROSTHESIS
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3604245
MDR Text Key16011045
Report Number0002249697-2014-00283
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue Number0590-3-047
Device Lot NumberG3925580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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