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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 40IDX58OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 40IDX58OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1219-40-458
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tissue Damage (2104); No Code Available (3191)
Event Date 03/20/2008
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
After review of medical records, the patient complains of drainage from the wound. Inspection revealed dehiscence of surgical incision. The patient was then revised for right total hip infection. Operative notes reported some purulent material were encountered. Inspection of the joint revealed that the capsule was deficient. It was also indicated that 200 ml blood loss and 1 unit transfusion of prbc. Doi: (b)(6) 2008 (stem); doi: (b)(6) 2008 (cup, head, liner); dor: (b)(6) 2008; right hip.
 
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Brand NamePINN MAR +4 NEUT 40IDX58OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9811743
MDR Text Key182772916
Report Number1818910-2020-07327
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295014874
UDI-Public10603295014874
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1219-40-458
Device Catalogue Number121940458
Device Lot NumberBW6A81000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2007
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: 03/10/2020 Patient Sequence Number: 1
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