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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM IMPLANT Back to Search Results
Catalog Number 623-00-36D
Device Problems Unstable (1667); No Apparent Adverse Event (3189)
Patient Problems Weakness (2145); Ambulation Difficulties (2544)
Event Date 09/18/2013
Event Type  Injury  
Event Description

Patient suffered from instability of the operated hip.

 
Manufacturer Narrative

Other devices listed in this report: cat. No. : 7849-1-050d; trident(tm) tc. Threaded cup; lot code: g2151278. Cat. No. : 7850-1-002; hipstar v40 stem n ø2; lot code: g2083685. Cat. No. : 6565-0-136; alumina v40-femoral head 36mm, +0mm nk; lot code: 25515001. At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience. Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.

 
Manufacturer Narrative

An event regarding loosening involving a hipstar stem was reported. Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event. A review of the provided information by a clinical consultant indicated, "this case relates to stem loosening as evident by the very brief revision surgery report. " there is no allegation of failure against the trident liner. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Patient suffered from instability of the operated hip.

 
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Brand NameTRIDENT 0 DEG INSERT 36MM
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4892685
MDR Text Key6535709
Report Number0002249697-2015-02197
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK062419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2012
Device Catalogue Number623-00-36D
Device LOT Number33RMHD
OTHER Device ID NumberSTERILE LOT# MG0704I053
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2007
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: 07/06/2015 Patient Sequence Number: 1
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