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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID Back to Search Results
Catalog Number 623-10-32F
Device Problems Packaging Problem; Physical Resistance/Sticking
Event Date 10/11/2018
Event Type  Malfunction  
Manufacturer Narrative

Review of the product history records indicate 31 devices were manufactured and accepted into final stock on (b)(6) 2017 with no reported relevant discrepancies. Based on the device identification the complaint databases were reviewed for similar reported events regarding packaging issue. Lot id - there have been no other events for the lot referenced. It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not available.

 
Event Description

The customer reported that the surgeon, (b)(6), was undertaking a hip procedure and on opening the package for the trident liner noticed that there was a sticky residue on the package between the paper layer and the plastic outer packaging. The implant was used to complete the case.

 
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Brand NameTRIDENT 10° X3 INSERT 32MM ID
Type of DeviceTRIDENT 10° X3 INSERT 32MM ID
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
evelyn ryan
raheen business park
limerick  NA
61498200
MDR Report Key8050799
Report Number0002249697-2018-03658
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number623-10-32F
Device LOT NumberHY26X5
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 Received10/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2017
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: 11/08/2018 Patient Sequence Number: 1
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