MAUDE MDR 7298403

MDR report key
7298403
Report number
2090010-2018-00003
Event key
0
Event type
3
Date of event
2018-01-08
Date received
2018-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PETER PERHACH
Address
5770 ARMADA DR. CARLSBAD CA 92008 US
Phone
760-760-7602
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNPLUG CEMENT RESTRICTORCEMENT OBTURATORISOTIS ORTHOBIOLOGICS, INCLZNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-260

Event Narratives#

N

Patient 1

NO PRODUCT SAMPLES, CTS, LATERAL RADIOGRAPHS, INITIAL OR SERIAL RADIOGRAPHS OR OTHER MEDICAL RECORDS HAVE BEEN PROVIDED. SINGLE EVENT RADIOGRAPH WAS RECEIVED AND CONFIRMS OSTEOLYSIS AT THE PROXIMAL END OF THE PROSTHETIC SHAFT. THERE IS OSTEOLYTIC RESORPTIVE CHANGES AT THE DISTAL TIP OF THE FEMORAL PROSTHESIS A MEDICAL REVIEW OF THE RADIOGRAPH NOTES, CEMENT DID NOT EXTEND BEYOND THE TIP OF THE PROSTHESIS, CORTICAL THINNING AT THE DISTAL TIP IS LIKELY INSIGNIFICANT WITHOUT FURTHER IMAGING TO CONFIRM. WITHIN IN MEDICAL PROBABILITY, AT 16 YEARS, THE SYNPLUG DID NOT CAUSE OR CONTRIBUTE TO THE PROXIMAL LOOSENING WHICH PER NOTE APPEARS TO BE CAUSING THE PATIENTS PAIN.

D

Patient 1

INITIAL HIP REPLACEMENT (HIP ARTHROPLASTY) SURGERY INVOLVING A HIP PROSTHESIS, THP CEMENT, AND SYNPLUG CEMENT RESTRICTOR, RIGHT SIDE OCCURRED IN 2002. ALLEGEDLY PATIENT HAD PAIN IN THE RIGHT LEG. CT SCAN WAS REPORTEDLY PERFORMED AND ALLEGEDLY A FINE LYSIS MARGIN WITH PATHOLOGICALLY METABOLISM FORMED AT THE PROXIMAL PORTION OF THE CEMENTED FEMORAL SHAFT WITH SIGNS OF LOOSENING. THE SURGEON ADDITIONALLY NOTED OSTEOLYSIS IN THE RIGHT DISTAL TIP OF THE PROSTHETIC SHAFT. CT SCANS WERE NOT PROVIDED. PLANS FOR REVISION ARE UNKNOWN.