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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM18X60MM KNEE STEMS

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DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM18X60MM KNEE STEMS Back to Search Results
Model Number 1513-18-060
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Clinical adverse event received for low hb value, post-operative event is not serious and is considered mild event is definitely not related to device and is definitely related to procedure.

 
Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Update ad 03 dec 2019. Clinical database information received. The database reports pain, problems walking and in doing the patient's usual activities and discomfort.

 
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Brand NameATUNE PRESSFIT STR STEM18X60MM
Type of DeviceKNEE STEMS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9450748
MDR Text Key170271861
Report Number1818910-2019-122271
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK160700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1513-18-060
Device Catalogue Number151318060
Device LOT NumberJ0412N
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2018
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: 12/11/2019 Patient Sequence Number: 1
Treatment
COMPETITOR BONE CEMENT
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