• 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. 1818910 ALTRX NEUT 36IDX54OD PINNACLE HIP SYSTEM : HIP POLY 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. 1818910 ALTRX NEUT 36IDX54OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 122136054
Device Problem Defective Device
Event Type  Malfunction  
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

Business unit: (b)(4). Date j&j became aware: 23/04/2018. Date of event: unknown. Name of reporter: (b)(6) clinical specialist depuy. Hospital name: (b)(6) hospital. Product name: marathon 36x54mm liner. Product code:1221-36-054. Lot/batch/exp: unknown. Was the product being used in a clinical trial? no. Did the event happen during a procedure? yes. Were you in the procedure at the time of the event? no. Event outcome/how was it managed? replacement implant used. Was there any consequence to the patient due to the event? no. Was the surgery prolonged due to the event? if yes, confirm how many minutes delay. No. Has the reporter facility indicated there may be legal action? no. Is the product available for return? yes. Please give a detailed explanation of the event: total hip replacement, surgeon insisted that marathon liner that was being used had a larger, internal diameter than stated (36mm internal ). He showed that a 36mm head seemed to not fit properly, within the 36mm liner. A replacement liner was used with no issue.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: examination of the returned device finds nothing outward to suggest product error. 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, a follow-up medwatch will be filed as appropriate.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALTRX NEUT 36IDX54OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380-0988
6103142063
MDR Report Key7530415
Report Number1818910-2018-60119
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number122136054
Device LOT NumberHM7078
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-