FDA.reportPublic FDA data

MAUDE MDR 9792865

MDR report key
9792865
Report number
1818910-2020-06914
Event key
0
Event type
3
Date of event
2018-12-21
Date received
2020-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN HIP FEMORAL HEADHIP FEMORAL HEADDEPUY ORTHOPAEDICS INC USKXAUNK HIP FEMORAL HEADR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0501. R

Event Narratives#

N

Patient 1

PRODUCT COMPLAINT # (B)(4). THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE FEMORAL STEM OR SLEEVE. IT IS REASONABLE TO ATTRIBUTE THE PAIN, OSTEOLYSIS, AND SOFT TISSUE DAMAGE, AND FOREIGN BODY REACTION TO THE ALTR ASSOCIATED WITH METAL-ON-METAL ARTICULATING SURFACE. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT COMPLAINS OF PAIN WITH SEVERE TROCHANTERIC OSTEOLYSIS ON RADIOGRAPH REPORTS. THE PATIENT WAS THEN REVISED FOR PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT HIP JOINT. OPERATIVE NOTES REPORTED THAT THE POSTERIOR SOFT TISSUE STRUCTURES WERE DEBILITATED BY EXTREME ADVERSE SOFT TISSUE REACTION. THERE WAS BROWN STAINED SYNOVIAL FLUID AND SEVERE ADVERSE SOFT TISSUE REACTION AROUND THE HIP REPLACEMENT. DOI: (B)(6) 2010; DOR: (B)(6) 2018; RIGHT HIP.