• 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 SELF CENT HIP 56X28 BLU HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

  • 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 SELF CENT HIP 56X28 BLU HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-56-000
Device Problem Naturally Worn (2988)
Patient Problem Pain (1994)
Event Date 03/14/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Medical records received. After review of medical records patient was revised was due to painful hemi arthroplasty with arthritis of left hip and obvious wear of his bipolar implant. Doi: (b)(6) 2017, dor: (b)(6) 2019, left hip 2nd revision. Please see (b)(4) left hip 1st revision.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSELF CENT HIP 56X28 BLU
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13175264
MDR Text Key283299738
Report Number1818910-2022-00295
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1035-56-000
Device Catalogue Number103556000
Device Lot NumberC22374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2016
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: 01/06/2022 Patient Sequence Number: 1
Treatment
ARTICUL/EZE BALL 28 +8.5 BL; SELF CENT HIP 56X28 BLU; UNK HIP FEMORAL STEM SUMMIT
-
-