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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 Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); No Code Available (3191)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (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
Painful post-op. This case is from health authority. It was reported that the patient was given bilateral total hip arthroplasty in 1999, and the postoperative recovery was smooth. Left hip revision was performed in 2009. On (b)(6) 2018, the patient suffered from a fall and felt painful in the right lower limb, x-ray showed fracture of right upper femur. The patient was given the incision of right femur under general anesthesia, reduction of internal fixation and revision of the right total hip joint on 12-17, pe liner was observed with obvious eccentric damaged, a large number of pale yellow inflammatory pseudotumor, the patient recovered smoothly after surgery.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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 Key9151865
MDR Text Key167613458
Report Number1818910-2019-107542
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received12/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/03/2019 Patient Sequence Number: 1
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