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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-52-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pocket Erosion (2013)
Event Date 02/16/2022
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.
 
Event Description
Revision of a metal inlay completed.There was erosion visible in the area of the prothesis.Primary need for the operation was a big tumor in the pelvis - during this surgery they exchanged the inlay to a poly inlay and the metal head to a delta ts ceramic head.
 
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
Revision of a metal inlay completed.There was erosion visible in the area of the prothesis.Primary need for the operation was a big tumor in the pelvis - during this surgery they exchanged the inlay to a poly inlay and the metal head to a delta ts ceramic head.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
There was no surgical delay.Affected side was the right side.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: visual examination of the device found nothing indicative of a device nonconformance.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.
 
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Brand Name
ARTICULEZE M HEAD 36MM +5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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 8DT
UK   LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13633910
MDR Text Key286330508
Report Number1818910-2022-03821
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295033936
UDI-Public10603295033936
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K980513
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 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1365-52-000
Device Catalogue Number136552000
Device Lot Number2059464
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2022
Initial Date FDA Received03/01/2022
Supplement Dates Manufacturer Received03/11/2022
05/06/2022
Supplement Dates FDA Received03/18/2022
05/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
ARTICULEZE M HEAD 36MM +5; PINNACLE MTL INS NEUT36IDX52OD
Patient Outcome(s) Required Intervention;
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