FDA Adverse Event Injury Summary report: N

SMITH & NEPHEW

MDR report key: 3212775 · Received July 3, 2013

Report

Report Number
MW5030787
Event Type
Injury
Date Received
July 3, 2013
Date of Event
November 7, 2011
Report Date
June 26, 2013
Manufacturer
SMITH & NEPHEW INC
Product Code
LZO
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

FIRST LEFT HIP SURGERY (B)(6) 2011 - LEFT HOSP FOR REHAB FACILITY (B)(6) 2011 - EVENING OF (B)(6) 2011 FELT STRANGE SENSATION AND HEARD NOSE IN HIP AREA. THE NEXT MORNING FOR REHAB TOLD THE TECH THIS INFO. SHE THEN HEARD THE NOISE ALONG WITH MY HUSBAND. SET ME UP FOR X-RAY IN THE AFTERNOON (B)(6) 2011. NEVER DID GET/HEAR OF THE RESULT FROM THIS X-RAY. MY HUSBAND CALLED MY SURGEON AND VISITED HIS OFFICE ON (B)(6) 2011. WAS TRANSPORTED TO HIS OFFICE IN THE AFTERNOON, HAD AN X-RAY (HE DID NOT HAVE THE X-RAY INFO FROM THE REHAB FACILITY). HE TALKED TO ME AND SAID I HAD TO HAVE A SECOND SURGERY SINCE THE DEVICE HAD COME APART IN MY HIP. HAD THE 2ND SURGERY ON (B)(6) 2011, AND AFTER THAT HAD REHAB AT MY HOME SINCE I DID NOT WANT TO GO BACK TO THE REHAB FACILITY. THAT WAS A NIGHTMARE OF A PLACE AND DID NOT GET THE NEEDED ASSISTANCE THERE. AT THE TIME OF THE INITIAL FALL WHICH LED TO THIS SURGERY, I HAD DISLOCATED MY RIGHT SHOULDER AND HAD DIFFICULTY IN HELPING MYSELF. WHENEVER I NEEDED SOME ASSISTANCE IT TOOK QUITE A TIME. YOU COULD NOT HOLD OFF NEEDING TO GET TO THE BATHROOM, HAD TO HELP MYSELF IN AND OUT OF THE BED, AND DO MY OTHER PERSONAL ISSUES MYSELF ALSO. THAT IS ANOTHER STORY, ONE THAT I WOULD NEVER CARE TO REPEAT AT THIS REHAB FACILITY. THE SECOND SURGERY TOOK PLACE ON (B)(6) 2011 AS STATED, AND FROM THERE ON OUT, NURSE CAME TO MY HOME FOR CHECK ON BLOOD, ETC. A PT PERSON CAME TO GIVE ME PT WHEN I COULD DO THIS, HAD A HOSP BED, TOILET FACILITY, WHEELCHAIR, ETC. AND MY HUSBAND TO ASSIST ME SINCE AT THIS POINT I COULD DO NOTHING FOR MYSELF. THE SECOND SURGERY WAS HARDER THAN THE FIRST IN SO MANY WAYS, HAD NOT HAD TIME TO HEAL FROM THE FIRST AND HAD TO DEAL WITH THE SECOND, WHICH TOOK MUCH LONGER IN THE ENTIRE PROCESS. WHEN I ASKED THE SURGEON DR (B)(6), SEVERAL TIMES, THE THIRD TIME I ASKED HIM WHAT HAPPENED TO ME HE JUST SAID "WE MAY NEVER KNOW" AND THIS IS NOT SATISFACTORY. THERE HAD TO BE A REASON FOR THIS HAPPENING, EITHER MALFUNCTION OF THE PART OR ERROR ON THE PART OF THE SURGEON. TO THIS DATE (B)(6) 2013 I STILL HAVE PROBLEMS WALKING, PAIN WHEN LYING ON THE LEFT SIDE IN BED, AND HAVE TO CONTINUE TAKING PAIN...

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
306057 SMITH & NEPHEW R3 XLPE 20 ACETABULAR LINER OXINIUM LZO SMITH & NEPHEW INC REF 71343600 11HM00515
306058 SMITH & NEPHEW 36 MM+0 12/14 JDI SMITH & NEPHEW INC REF 71335752 11HM18806
306059 SMITH & NEPHEW UHMWPE, ZR-2.5 NB KWY SMITH & NEPHEW INC 11DM08515
306330 SMITH & NEPHEW FEMORAL HEAD KWY SMITH & NEPHEW INC 71343603 11GM14927

Patients

Seq Age Sex Outcome Treatment
1 69 YR Hospitalization| O| R| S