FDA.reportPublic FDA data

MAUDE MDR 5003654

MDR report key
5003654
Report number
0002249697-2015-02676
Event key
0
Event type
3
Date of event
1999-07-07
Date received
2015-08-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. WILLIAM HANNA
Address
325 CORPORATE DRIVE MAHWAH NJ 07430 US
Phone
201-201-2018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MMIMPLANTSTRYKER ORTHOPAEDICS-MAHWAHJDK2051-205240491401R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-1401. H; 2. R

Event Narratives#

N

Patient 1

THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

IT WAS REPORTED AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 1999, A STRYKER TRIDENT ACETABULAR HIP SYSTEM CERAMIC ON CERAMIC WAS IMPLANTED IN THE PATIENT. ON OR ABOUT (B)(6) 2002, (B)(6) 2003, THE PATIENT ALLEGEDLY SUFFERED REPEATED DISLOCATIONS OF THE LEFT HIP, LAX GAIT. ON OR ABOUT (B)(6) 2003, THE PATIENT ALLEGEDLY UNDERWENT REVISION SURGERY OF THE LEFT TRIDENT SYSTEM.

N

Patient 1

CONCLUSION: BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. THE EVENT INDICATES THE HIP DISLOCATED, WHICH OCCURS WHEN THE HEAD DISLOCATES FROM THE LINER. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE REMAINING DEVICES. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

D

Patient 1

IT WAS REPORTED AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 1999, A STRYKER TRIDENT ACETABULAR HIP SYSTEM CERAMIC ON CERAMIC WAS IMPLANTED IN THE PATIENT. ON OR ABOUT (B)(6) 2002, (B)(6) 2003, (B)(6) 2003 AND (B)(6) 2003, THE PATIENT ALLEGEDLY SUFFERED REPEATED DISLOCATIONS OF THE LEFT HIP, LAX GAIT. ON OR ABOUT (B)(6) 2003, THE PATIENT ALLEGEDLY UNDERWENT REVISION SURGERY OF THE LEFT TRIDENT SYSTEM.