• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887352
Device Problem Naturally Worn (2988)
Patient Problems Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Event Date 03/12/2012
Event Type  Injury  
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. (b)(4).
 
Event Description
Litigation alleges metal wear/metallosis and elevated metal ions. Doi: (b)(6) 2008 - dor: (b)(6) 2012 (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. If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE MTL INS NEUT36IDX52OD
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 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key8204225
MDR Text Key131695808
Report Number1818910-2018-79430
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2013
Device Catalogue Number121887352
Device Lot Number2650313
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 Received01/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
-
-