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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM ST,36+6L NK,11X16X150 S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US SROM STM ST,36+6L NK,11X16X150 S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 563517
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 09/18/2013
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate.

 
Event Description

Patient was revised to address metallosis. Update rec'd 11/4/2013 - legal claim received. There is no new additional information that would affect the investigation. Records are attached for further review. The complaint was updated on: 11/25/2013. Update: 03/18/2014 - litigation received. Litigation alleges pain, elevated metal ion levels, popping and clicking, instability and numbness. There is no new additional information that would affect the investigation. This complaint was updated on: 04/03/2014. Update 07/21/2015 - pfs and medical records received. After review of the medical records for mdr reportability, an unknown stem is being added to the alleged high metal ions. No labs were provided or part/lot. The complaint was updated on: 08/18/2015.

 
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions. Ref. Wwcapa (b)(4). Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.

 
Manufacturer Narrative

Depuy still considers this investigation closed at this time.

 
Event Description

Update 05/18/2016 - pfs and medical records received. After review of the medical records for mdr reportability, the taper sleeve is being added for the alleged high metal ion levels (no labs). The complaint was updated on: 06/09/2016.

 
Manufacturer Narrative

Additional narrative: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions. (b)(4). Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.

 
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Brand NameSROM STM ST,36+6L NK,11X16X150
Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopedics drive
warsaw, IN 46581-0988
6107428552
MDR Report Key5010816
MDR Text Key23304509
Report Number1818910-2015-28369
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK954935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR,HEALTH P
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number563517
Device LOT Number2924651
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 Received09/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/19/2009
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: 08/18/2015 Patient Sequence Number: 1
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