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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 542-11-54F
Device Problem Malposition of Device
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Patients hip was revised for dislocation. All implants were removed and replaced with trident ii tritanium multihole shell, mdm liner, securfit stem and 28mm biolox head. This is the second revision. Update 01/june/2020 wg: left hip (patient has had bilateral revisions. The shell and screw (implanted (b)(6) 2016), liner, head, sleeve, stem (implanted (b)(6) 2020) were revised. Update: "the stem was revised because it was undersized and had already had a multiple heads on the trunion. The surgeon wanted to properly size the femoral stem and wanted a fresh trunion. The shell was revised for inadequate anteversion. The dislocation was of the femoral head out of the liner. The surgeon declined any further information. ".

 
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Brand NameTRIDENT PSL HA CLUSTER 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
marisol santiago
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key10183970
Report Number0002249697-2020-01258
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number542-11-54F
Device Catalogue Number542-11-54F
Device LOT NumberPW4163
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 Received05/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2015
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: 06/23/2020 Patient Sequence Number: 1
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