• 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 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC 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 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121881752
Device Problem Fracture (1260)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Event Date 11/16/2021
Event Type  Injury  
Event Description
Liner breakage post-op. The patient underwent hip replacement surgery in 2020. During the second surgery in 2021, implanted ceramic liner was found to be fractured in patient, while the implanted corail hip and ceramic head were found to be worn. The patient had completed the second surgery to explant the fractured and worn implants, and still used johnson & johnson products to complete the second surgery. The patient was stable now. Doi: (b)(6) 2020. Dor: (b)(6) 2021; unknown hip.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEA DELTA CER INSERT 36IDX52OD
Type of DevicePINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 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
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13001748
MDR Text Key282211737
Report Number1818910-2021-27868
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number121881752
Device Lot Number9428210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2020
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: 12/14/2021 Patient Sequence Number: 1
Treatment
CORAIL2 STD SIZE 11; DELTA CER HEAD 12/14 36MM +5; EA DELTA CER INSERT 36IDX52OD
-
-