NEXGEN STEM EXTENSION STRAIGHT
Report
- Report Number
- 2648920-2013-00035
- Event Type
- Injury
- Date Received
- January 25, 2013
- Report Date
- December 29, 2012
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- NJL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
AN X-RAY IMAGE WAS PROVIDED FROM POST-OP; IT DOES NOT APPEAR THAT THERE ARE ANY SIGNIFICANT ISSUES WITH THE DEVICES, WITH REGARD TO COMPONENT POSITION, ETC. ADDITIONALLY, IT IS NOT APPARENT IF THE SET SCREWS HAVE MIGRATED OUT OF THE MORSE TAPER/STEM CONNECTION AREA IN THE (B)(4) SURGICAL TECHNIQUE, IT STATES TO STRIKE THE STEM EXTENSION ONLY ONCE TO SEAT THE TAPER; STRIKING TWICE MAY LOOSEN THE LOCKING MECHANISM. ADDITIONALLY, IT IS RECOMMENDED TO TORQUE BOTH SET SCREWS BY HAND TO ENSURE THE STEM IS LOCKED ON TIGHTLY. AS NO OPERATIVE NOTES WERE SUPPLIED, IT IS UNK IF SURGICAL TECHNIQUE WAS A FACTOR. WITHOUT SUFFICIENT EVIDENCE, ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD¿L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
IT IS REPORTED AN (B)(4) STEM WAS IMPACTED AND SECURED WITH A SCREW. POST-OP X-RAYS DONE 2 DAYS LATER REVEALED THAT THE STEM WAS LOOSE AND HAD MIGRATED IN THE FEMORAL CANAL. REVISION SURGERY IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36104 | NEXGEN STEM EXTENSION STRAIGHT | NJL | ZIMMER MANUFACTURING B.V. | 61675771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |