DISTAL FEMUR JTS
Report
- Report Number
- 3004105610-2018-00098
- Event Type
- Injury
- Date Received
- October 15, 2018
- Date of Event
- September 17, 2018
- Report Date
- March 20, 2019
- Manufacturer
- STANMORE IMPLANTS WORLDWIDE
- Product Code
- KRO
- PMA / PMN Number
- K133152
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
CORRECTED DATA: DEVICE NAME WAS CORRECTED FROM DISTAL FEMUR TO DISTAL FEMUR JTS. PMA 510(K) # WAS CORRECTED FROM K140898 TO K133152. ADDITIONAL MANUFACTURE NARRATIVE: AN EVENT REGARDING ALLEGED FRACTURE OF THE TIBIAL HINGE INVOLVING A JTS DISTAL FEMUR WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. CLINICIAN REVIEW: THE IMPLANT IN SITU WAS FOR A JTS DISTAL FEMORAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2011. THE SURGEON REPORTED THAT THE PATIENT HAD A FALL AND THE KNEE HINGE HAS BROKEN. THE MEDICAL IMAGING PROVIDED SHOWS THAT THE TIBIAL PART OF THE HINGE HAS FRACTURED, AND THE KNEE JOINT HAS DISLOCATED. THE FEMORAL STEM HAS MOVED ANTERIORLY, ESPECIALLY WHEN THE KNEE IS IN FLEXION. THE ABOVE RADIOGRAPHIC ASSESSMENT HAS CONFIRMED THE REASON FOR REVISION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE ONE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 18 AUG 2011 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS. CONCLUSIONS: FOLLOWING A PATIENT FALL THE TIBIAL HINGE WAS REPORTED TO HAVE FRACTURED AND THE SURGEON REPORTED THAT THE AXLE CAP WAS REMOVED FROM ITS PLACE, THE SURGEON DOES NOT KNOW IF THE DISASSOCIATION OF THE AXLE CAP OCCURRED WHEN THE IMPLANT WAS BROKEN OR BEFORE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS DEVICE RETURN, THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED. REVISION SURGERY TOOK PLACE ON (B)(6) 2018 DUE TO FRACTURED TIBIAL HINGE WHEREBY JTS DISTAL FEMUR COMPONENTS WERE EXPLANTED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.
IT WAS REPORTED THAT THE PATIENT WAS WALKING, LOST CONTROL OF HIS LEG, AND FELL. X-RAYS INDICATE THE HINGE OF THE PATIENT'S KNEE CONSTRUCT BROKE. A REVISION HAS NOT YET BEEN PERFORMED BUT IS BEING PLANNED TO EXCHANGE THE TIBIAL COMPONENT. FEMORAL COMPONENT REPORTED AS WELL-FIXED AND WILL NOT BE REVISED DUE TO ANY ALLEGATIONS AGAINST THE DEVICE.
AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.
IT WAS REPORTED THAT THE PATIENT WAS WALKING, LOST CONTROL OF HIS LEG, AND FELL. X-RAYS INDICATE THE HINGE OF THE PATIENT'S KNEE CONSTRUCT BROKE. A REVISION HAS NOT YET BEEN PERFORMED BUT IS BEING PLANNED TO EXCHANGE THE TIBIAL COMPONENT. FEMORAL COMPONENT REPORTED AS WELL-FIXED AND WILL NOT BE REVISED DUE TO ANY ALLEGATIONS AGAINST THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808231 | DISTAL FEMUR JTS | LIMB SALVAGE SYSTEM | KRO | STANMORE IMPLANTS WORLDWIDE | PIN 16331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Hospitalization| R | SMBPR00 SMILES KNEE BUMPERS EXSM B7775| SMBSH00 SMILES KNEE BUSHES EXSMALL B7776| SMCAP01 AXLE CAP B8537| SMTBC00G PASSIVE GROWER TIB BEARING XSM B8462 |