NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM
Report
- Report Number
- 0002249697-2016-03378
- Event Type
- Injury
- Date Received
- October 27, 2016
- Date of Event
- September 29, 2016
- Report Date
- January 9, 2017
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- PMA / PMN Number
- K141056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRI PRESS-FIT STEM 22MM X 100MM; CAT# 5565-S-022; LOT# M8L14A. TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 4MM; CAT# 5570-S-040; LOT# 0036732K. TRI POST AUGMENT SZ4 5MM; CAT# 5543-A-400; LOT# TW4Z, QTY. 2. TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 4 LEFT; CAT# 5541-A-401; LOT# U4YA. TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 4 LEFT; CAT# 5540-A-401; LOT# IIYE. TRI TS FEMUR SZ4 LEFT; CAT# 5512-F-401; LOT# UTVV. TRI PRESS-FIT STEM 18MM X 100MM; CAT# 5565-S-018; LOT# M9A15A. TRI TS BASEPLATE SIZE 4; CAT# 5521-B-400; LOT# VG4EA. TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 6MM; CAT# 5570-S-060; LOT# M7T51L. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.
AN EVENT REGARDING DISLOCATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED PRODUCT WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW OF MEDICAL RECORDS BY A CONSULTING CLINICIAN NOTED: "UNDATED X-RAY DOES NOT CONFIRM EVENT, NEED OPERATIVE REPORTS, CLINICAL AND PAST MEDICAL HISTORY, NEED DATED X-RAYS AND EXAMINATION OF EXPLANTED COMPONENTS." -DEVICE HISTORY REVIEW: INDICATED THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT PROVISION OF INFORMATION. EVENT NOTES THAT PATIENT TORE HIS LATERAL COLLATERAL LIGAMENT, WHICH COULD HAVE LED TO DISLOCATION. FURTHER INFORMATION SUCH AS: RETURN OF REPORTED DEVICES, X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION TO DETERMINE ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
PATIENT UNDERWENT A REVISION OF A COMPETITOR TOTAL KNEE ON (B)(6) WITH A STRYKER TS. OPERATION WAS COMPLETED SUCCESSFULLY. PATIENT SUBSEQUENTLY TORE HIS LATERAL COLLATERAL LIGAMENT AND DISLOCATED. IT WAS DETERMINED THAT HE WOULD NEED A HINGED COMPONENT FOR STABILITY. HE WAS SUCCESSFULLY REVISED ON (B)(6).
PATIENT UNDERWENT A REVISION OF A COMPETITOR TOTAL KNEE ON (B)(6) WITH A STRYKER TS. OPERATION WAS COMPLETED SUCCESSFULLY. PATIENT SUBSEQUENTLY TORE HIS LATERAL COLLATERAL LIGAMENT AND DISLOCATED. IT WAS DETERMINED THAT HE WOULD NEED A HINGED COMPONENT FOR STABILITY. HE WAS SUCCESSFULLY REVISED ON (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711562 | NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | YH8JW6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |