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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887458
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Ischemic Heart Disease (2493); Ambulation Difficulties (2544); Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. (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
Ppf, pfs and medical records received. Ppf has no allegation. Pfs alleges pain, gain weight, dm, heart issues, walking difficulty, decrease rom, metallosis and patient suspect metal in blood caused memory impairment. After review of medical records, no revision was scheduled due to diabetes and heart condition as well as throat issue, patient could not be intubated and that a revision surgery would be out of the question. Patient also reported concerns about metallosis. Doi: (b)(6) 2008, dor: none reported, left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Device history lot: a device manufacturing (mre) review will not be performed even when product/ lot information is known. Per (b)(4) it has been determined that, for the mom platform and related allegations an mre is not required.
 
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Brand NamePINNACLE MTL INS NEUT40IDX58OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11660959
MDR Text Key245336352
Report Number1818910-2021-07852
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2013
Device Catalogue Number121887458
Device Lot Number2548854
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 Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC-2; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 8 STD OFFSET
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