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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 6020-0435
Device Problems Loss of Osseointegration; Osseointegration Problem
Event Date 12/28/2008
Event Type  Injury  
Manufacturer Narrative

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. Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. Not returned.

 
Event Description

Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks. Patient also reported that his doctor mentioned bone loss and loosening in his hip. Patient would like to know if his implants were part of a recall.

 
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Brand NameACCOLADE TMZF HIP STEM #4
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
collin neitzel
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key9693266
Report Number0002249697-2020-00259
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2020
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2013
Device MODEL Number6020-0435
Device Catalogue Number6020-0435
Device LOT Number26167401
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 Received02/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2008
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: 02/11/2020 Patient Sequence Number: 1
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