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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number 103542000
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: examination of the returned devices confirms the reported observation. A root cause could not however be conclusively determined. 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 will be filed as appropriate.
 
Event Description
Complaint was that a 42mm diameter cathcart head would not fit properly onto a 28mm inner metal head.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: examination of the returned devices confirms the reported observation. A root cause could not however be conclusively determined. 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.
 
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Brand NameSELF CENT HIP 42X28 RUST
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8190272
MDR Text Key131207919
Report Number1818910-2018-79024
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number103542000
Device Lot NumberHG2454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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