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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0 HIP OTHER IMPLANT

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DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0 HIP OTHER IMPLANT Back to Search Results
Catalog Number 136310000
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 07/20/2017
Event Type  Injury  
Manufacturer Narrative
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
Update sep12, 2017. Medical records reviewed. It is indicated the patient received a hemiarthroplasty of the right hip due to displaced femoral neck fracture post fall. Approximately 7 weeks post hemiarthroplasty the patient presented to the ed with right hip pain. Infection workup revealed positive staphylococcus epidermis; the final impression concluded to be prosthetic joint infection. It is also indicated within the medical records that the patient went on to receive a revision of the femoral component and head exchange with incision and debridement and placement of antibiotic beads. Updated 10-4-2017.
 
Manufacturer Narrative
(b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. 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. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Der states that patient had hemi hip implanted on (b)(6) 2017. Patient started experiencing pain and was brought back to or last (b)(6) 2017 and it was determined that patient had infected hemi hip. The head ball and sleeve were removed and a hip joint washout was performed. The original stem was left implanted.
 
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Brand NameTAPERED SPACER ARTICUL/EZE +0
Type of DeviceHIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key6803933
MDR Text Key104292498
Report Number1818910-2017-23069
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032670
UDI-Public10603295032670
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136310000
Device Lot NumberH64478
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/18/2017 Patient Sequence Number: 1
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