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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Edema (1820); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994); Renal Failure (2041); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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.(b)(4).
 
Event Description
After review of medical records, it was indicated that patient had a complicated postoperative course with hypotension as well as an acute kidney injury.This improved after fluid resuscitation and 1 unit of prbc.It was also indicated that there was mild rle edema, ecchymosis, pain with rom, swelling and tenderness.Doi: (b)(6) 2019 - dor: none reported (right hip).Doi: (b)(6) 2008 (stem).Please see pc-(b)(4) for the 1st revision surgery.
 
Manufacturer Narrative
Product complaint #(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 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.H10 additional narrative: corrected: h5.
 
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Brand Name
UNKNOWN HIP FEMORAL HEAD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10159236
MDR Text Key195295032
Report Number1818910-2020-13874
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/04/2020
Initial Date FDA Received06/16/2020
Supplement Dates Manufacturer Received07/26/2020
Supplement Dates FDA Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SUMMIT DUOFIX TAP SZ6 HI OFF; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN SCREW; UNKNOWN SCREW; UNKNOWN SCREW; SUMMIT DUOFIX TAP SZ6 HI OFF; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN SCREW; UNKNOWN SCREW; UNKNOWN SCREW
Patient Outcome(s) Required Intervention;
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