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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 HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS, INC. 1818910 SELF CENT HIP 45X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number 103545000
Device Problems Disconnection (1171); Fracture (1260)
Patient Problem Not Applicable (3189)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative
(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
Patient was revised to address disassociation. Patient presented with disassociated bipolar construct. Upon incision and inspection of hip joint, it was discovered that the polyethylene portion of the construct was fractured in half. The 28mm head, 45mm bipolar shell, and the 2 pieces of polyethylene were all recovered from the patient w/o any adverse events. A new bipolar construct was chosen and implanted w/o issue. It was also reported that the 28mm head from the bipolar construct was loose. Doi: unknown; dor: (b)(6) 2018; unknown hip.
 
Manufacturer Narrative
(b)(4). Investigation summary no device associated with this report was received for examination. 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 45X28 GRY
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7812545
MDR Text Key118109611
Report Number1818910-2018-67607
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 08/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103545000
Device Lot NumberC38798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2016
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: 08/24/2018 Patient Sequence Number: 1
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