• 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 ALTRX NEUT 40IDX56OD 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 US ALTRX NEUT 40IDX56OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1221-40-056
Device Problems Difficult to Insert; Device-Device Incompatibility
Event Date 05/13/2020
Event Type  Malfunction  
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

It was reported that the 40mm liner would not lock in gription cup. Replaced with 36 mm liner. Doe: (b)(6) 2020, left hip.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALTRX NEUT 40IDX56OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key10104139
Report Number1818910-2020-12881
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1221-40-056
Device Catalogue Number122140056
Device LOT NumberJ6076H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/20/2019
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: 06/01/2020 Patient Sequence Number: 1
Treatment
ALTRX NEUT 40ID X 56OD
UNKNOWN HIP ACETABULAR CUP
-
-