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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 502-03-50D
Device Problem Loss of Osseointegration
Event Date 06/08/2018
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 reported lot. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Surgeon revised a loose tritanium cup to a trident ii. Original surgery was on (b)(6) 2016 via mako. Surgeon was not satisfied with the ingrowth of the shell on x-ray. On explantation, nearly no ingrowth was observable. Patient was revised to a larger shell with 3 screws, a trident 0° insert, and biolox v40 +0 head.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
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
brad curtis
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7659708
Report Number0002249697-2018-02060
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number502-03-50D
Device LOT NumberXM1346
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/10/2016
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: 07/03/2018 Patient Sequence Number: 1
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