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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_SHC
Device Problems Loss of Osseointegration; Osseointegration Problem
Event Date 01/24/2020
Event Type  Injury  
Manufacturer Narrative

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. Device not returned.

 
Event Description

It was reported that the patient's head was revised. As reported by rep: "loose acetabular shell. " patient was revised to stryker and competitor devices. Update per response: "there are no allegations from the surgeon against the 3 implants" (mdm liner, adm/mdm poly insert & v-40 femoral head).

 
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Brand NameUNKNOWN TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
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-CORK
ida industrial estate
carrigtwohill NA
IE  NA
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale , FL 33317
9546280700
MDR Report Key9739859
Report Number0002249697-2020-00372
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SHC
Device LOT NumberUNKNOWN
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 Received03/05/2020
Was Device Evaluated By Manufacturer? No
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: 02/21/2020 Patient Sequence Number: 1
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