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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SELF CENT HIP 45X28 GRY HIP OTHER IMPLANT

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DEPUY ORTHOPAEDICS, INC. 1818910 SELF CENT HIP 45X28 GRY HIP OTHER IMPLANT Back to Search Results
Catalog Number 103545000
Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 08/16/2017
Event Type  malfunction  
Manufacturer Narrative
Examination of the returned devices was unable to confirm the reported issue. 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.
 
Manufacturer Narrative
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 28 head was moving inside the bi-polar shell more than usual and the surgeon didn't want to implant it.
 
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Brand NameSELF CENT HIP 45X28 GRY
Type of DeviceHIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6868198
MDR Text Key101902615
Report Number1818910-2017-24740
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number103545000
Device Lot Number750004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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