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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887354
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Cardiac Arrest (1762); Hearing Impairment (1881); Depression (2361); Not Applicable (3189)
Event Date 09/01/2013
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle index procedure. Reason for revision: elevated/high metal ions. Doi: (b)(6) 2009; (b)(6) 2013; left hip.
 
Manufacturer Narrative
(b)(4). Investigation summary no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NamePINNACLE MTL INS NEUT36IDX54OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7538041
MDR Text Key109048177
Report Number1818910-2018-60364
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2014
Device Catalogue Number121887354
Device Lot Number2910848
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/11/2009
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: 05/23/2018 Patient Sequence Number: 1
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