VIVACIT-E®
Report
- Report Number
- 14605118
- Event Type
- Injury
- Date Received
- June 6, 2022
- Date of Event
- May 6, 2022
- Report Date
- May 29, 2022
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- UDI-DI
- 00889024572713
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE PATIENT HAD A BILATERAL TOTAL HIP ARTHROPLASTY (THA) DONE A FEW YEARS BACK AND HAD DONE WELL. PATIENT, SUBSEQUENTLY, HAD AN EXTENSIVE LUMBOSACRAL FUSION, AFTER WHICH POINT THE PATIENT DISLOCATING TOTAL HIP REPLACEMENT ANTERIORLY. CT SCANS AND ENGINEERS WITH THE CORIN GROUP OPTIMIZED POSITIONING SYSTEM (OPS) ANALYZED PATIENT'S HIPS IN THE SITTING AND STANDING POSITION AND GAVE RECOMMENDATIONS FOR THE IDEAL LOCATION OF THE ACETABULAR COMPONENT. SURGICAL/CLINICAL STAFF THEN WENT AHEAD AND DID THAT ACETABULAR REVISION APPROXIMATELY EIGHT WEEKS AGO. PATIENT HAD DONE WELL AND AT HER SIX-WEEK POSTOPERATIVE VISIT, PATIENT EXPRESSED ABSOLUTELY NO PAIN AND EVERYTHING WAS DOING VERY, VERY WELL. ABOUT ONE WEEK AGO, SOMETHING HAPPENED AND PATIENT DISLOCATED HER HIP. THERE WAS SOME CONCERN THAT THERE MAY HAVE BEEN MORE GOING ON THAN WHAT THE PATIENT SAID INITIALLY. HOWEVER, SHE SAID THAT SHE FLEXED HER HIP PAST 90 DEGREES IN THE SHOWER, ROTATED INTERNALLY AND THEN ADDUCTED HER FEMUR. THIS CAUSED THE FIRST DISLOCATION. OVER ONE WEEK SHE HAD TWO SUBSEQUENT DISLOCATIONS. BECAUSE OF THIS, WE DECIDED TO DO A REVISION. DESCRIPTION OF CATASTROPHIC FAILURE OF THE DUAL MOBILITY CONSTRUCT: AFTER THE FASCIA WAS OPENED, SURGICAL TEAM FOUND THE POLYETHYLENE LARGE BALL SITTING IN THE SOFT TISSUES INDEPENDENT OF THE OXINIUM FEMORAL HEAD, WHICH WAS STILL AFFIXED SUPERIORLY TO THE TRUNNION. THE REPRESENTATIVE IN THE ROOM WAS ASKED WHAT THE REPORTED INCIDENCE OF THIS WAS AND HE WAS AWARE THAT THERE HAD BEEN ONE REPORTED INCIDENCE OF THIS.
THE PATIENT HAD A BILATERAL TOTAL HIP ARTHROPLASTY (THA) DONE A FEW YEARS BACK AND HAD DONE WELL. PATIENT, SUBSEQUENTLY, HAD AN EXTENSIVE LUMBOSACRAL FUSION, AFTER WHICH POINT THE PATIENT DISLOCATING TOTAL HIP REPLACEMENT ANTERIORLY. CT SCANS AND ENGINEERS WITH THE CORIN GROUP OPTIMIZED POSITIONING SYSTEM (OPS) ANALYZED PATIENT'S HIPS IN THE SITTING AND STANDING POSITION AND GAVE RECOMMENDATIONS FOR THE IDEAL LOCATION OF THE ACETABULAR COMPONENT. SURGICAL/CLINICAL STAFF THEN WENT AHEAD AND DID THAT ACETABULAR REVISION APPROXIMATELY EIGHT WEEKS AGO. PATIENT HAD DONE WELL AND AT HER SIX-WEEK POSTOPERATIVE VISIT, PATIENT EXPRESSED ABSOLUTELY NO PAIN AND EVERYTHING WAS DOING VERY, VERY WELL. ABOUT ONE WEEK AGO, SOMETHING HAPPENED AND PATIENT DISLOCATED HER HIP. THERE WAS SOME CONCERN THAT THERE MAY HAVE BEEN MORE GOING ON THAN WHAT THE PATIENT SAID INITIALLY. HOWEVER, SHE SAID THAT SHE FLEXED HER HIP PAST 90 DEGREES IN THE SHOWER, ROTATED INTERNALLY AND THEN ADDUCTED HER FEMUR. THIS CAUSED THE FIRST DISLOCATION. OVER ONE WEEK SHE HAD TWO SUBSEQUENT DISLOCATIONS. BECAUSE OF THIS, WE DECIDED TO DO A REVISION. DESCRIPTION OF CATASTROPHIC FAILURE OF THE DUAL MOBILITY CONSTRUCT: AFTER THE FASCIA WAS OPENED, SURGICAL TEAM FOUND THE POLYETHYLENE LARGE BALL SITTING IN THE SOFT TISSUES INDEPENDENT OF THE OXINIUM FEMORAL HEAD, WHICH WAS STILL AFFIXED SUPERIORLY TO THE TRUNNION. THE REPRESENTATIVE IN THE ROOM WAS ASKED WHAT THE REPORTED INCIDENCE OF THIS WAS AND HE WAS AWARE THAT THERE HAD BEEN ONE REPORTED INCIDENCE OF THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306427 | VIVACIT-E® | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS | LPH | ZIMMER, INC. | 110031013 | 64689634 | 00889024572713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22265 DA | Female | Hospitalization| O| R |