TRIDENT 0 DEG INSERT 40MM
Report
- Report Number
- 0002249697-2023-00741
- Event Type
- Injury
- Date Received
- July 3, 2023
- Date of Event
- May 1, 2023
- Report Date
- September 5, 2023
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- UDI-DI
- 07613327025361
- PMA / PMN Number
- K061434
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.
REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: ""THIS PATIENT UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY THROUGH A POSTERIOR APPROACH AND FOUR DAYS AFTER SURGERY REQUIRED REVISION AFTER A FALL IN WHICH HE SUSTAINED A POSTERIOR DISLOCATION OF THE HIP. A REVISION WAS CARRIED OUT DURING WHICH BOTH COMPONENTS WERE CHANGED. FOLLOWING THAT REVISION THE PATIENT SUSTAINED FOUR DISLOCATIONS AND APPROXIMATELY 1 YEAR LATER HE REQUIRED ANOTHER REVISION WITH INSERTION OF A CONSTRAINED LINER. POST REVISION XRAYS REVEALED SATISFACTORY APPEARANCE OF THE CONSTRAINED LINER AND TOTAL HIP ARTHROPLASTY. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF RECURRENT INSTABILITY ABOUT THE HIP ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS AND PATIENT FACTORS INCLUDING ACTIVITY PROFILE, AND BMI. IN THIS CASE TRAUMA PLAYED A SIGNIFICANT ROLE. IN THIS CASE THE SURGEON FELT IT WAS NECESSARY TO CHANGE BOTH COMPONENTS IN ORDER TO GAIN STABILITY OF THE HIP. POSSIBILITY OF IMPINGEMENT AS A CONTRIBUTING FACTOR AS WELL AS THE TRAUMA CAN BE CONSIDERED. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF." -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "THIS PATIENT UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY THROUGH A POSTERIOR APPROACH AND FOUR DAYS AFTER SURGERY REQUIRED REVISION AFTER A FALL IN WHICH HE SUSTAINED A POSTERIOR DISLOCATION OF THE HIP. A REVISION WAS CARRIED OUT DURING WHICH BOTH COMPONENTS WERE CHANGED. FOLLOWING THAT REVISION THE PATIENT SUSTAINED FOUR DISLOCATIONS AND APPROXIMATELY 1 YEAR LATER HE REQUIRED ANOTHER REVISION WITH INSERTION OF A CONSTRAINED LINER. POST REVISION XRAYS REVEALED SATISFACTORY APPEARANCE OF THE CONSTRAINED LINER AND TOTAL HIP ARTHROPLASTY. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF RECURRENT INSTABILITY ABOUT THE HIP ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS AND PATIENT FACTORS INCLUDING ACTIVITY PROFILE, AND BMI. IN THIS CASE TRAUMA PLAYED A SIGNIFICANT ROLE. IN THIS CASE THE SURGEON FELT IT WAS NECESSARY TO CHANGE BOTH COMPONENTS IN ORDER TO GAIN STABILITY OF THE HIP. POSSIBILITY OF IMPINGEMENT AS A CONTRIBUTING FACTOR AS WELL AS THE TRAUMA CAN BE CONSIDERED. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF." THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "THIS PATIENT UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY THROUGH A POSTERIOR APPROACH AND FOUR DAYS AFTER SURGERY REQUIRED REVISION AFTER A FALL IN WHICH HE SUSTAINED A POSTERIOR DISLOCATION OF THE HIP. A REVISION WAS CARRIED OUT DURING WHICH BOTH COMPONENTS WERE CHANGED. FOLLOWING THAT REVISION THE PATIENT SUSTAINED FOR DISLOCATIONS AND APPROXIMATELY 1 YEAR LATER HE REQUIRED ANOTHER REVISION WITH INSERTION OF A CONSTRAINED LINER. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF RECURRENT INSTABILITY ABOUT THE HIP ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS AND PATIENT FACTORS INCLUDING ACTIVITY PROFILE, AND BMI. IN THIS CASE TRAUMA PLAYED A SIGNIFICANT ROLE. IN THIS CASE THE SURGEON FELT IT WAS NECESSARY TO CHANGE BOTH COMPONENTS IN ORDER TO GAIN STABILITY OF THE HIP. POSSIBILITY OF IMPINGEMENT AS A CONTRIBUTING FACTOR AS WELL AS THE TRAUMA CAN BE CONSIDERED. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF." PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "THIS PATIENT UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY THROUGH A POSTERIOR APPROACH AND FOUR DAYS AFTER SURGERY REQUIRED REVISION AFTER A FALL IN WHICH HE SUSTAINED A POSTERIOR DISLOCATION OF THE HIP. A REVISION WAS CARRIED OUT DURING WHICH BOTH COMPONENTS WERE CHANGED. FOLLOWING THAT REVISION THE PATIENT SUSTAINED FOR DISLOCATIONS AND APPROXIMATELY 1 YEAR LATER HE REQUIRED ANOTHER REVISION WITH INSERTION OF A CONSTRAINED LINER. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF RECURRENT INSTABILITY ABOUT THE HIP ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS AND PATIENT FACTORS INCLUDING ACTIVITY PROFILE, AND BMI. IN THIS CASE TRAUMA PLAYED A SIGNIFICANT ROLE. IN THIS CASE THE SURGEON FELT IT WAS NECESSARY TO CHANGE BOTH COMPONENTS IN ORDER TO GAIN STABILITY OF THE HIP. POSSIBILITY OF IMPINGEMENT AS A CONTRIBUTING FACTOR AS WELL AS THE TRAUMA CAN BE CONSIDERED. I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF." THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
PATIENT REPORTED PAIN AND 2 DISLOCATIONS AND CLOSED REDUCTIONS SINCE REVISION SURGERY. UPDATE: PATIENT HAD A REVISION DUE TO DISLOCATION ON (B)(6) 2022 & ON (B)(6) 2023. THIS PI IS FOR REVISION ON (B)(6) 2023.
PATIENT REPORTED PAIN AND 2 DISLOCATIONS AND CLOSED REDUCTIONS SINCE REVISION SURGERY. UPDATE: PATIENT HAD A REVISION DUE TO DISLOCATION ON (B)(6) 2022 & ON (B)(6) 2023. THIS PI IS FOR REVISION ON (B)(6) 2023.
PATIENT REPORTED PAIN AND 2 DISLOCATIONS AND CLOSED REDUCTIONS SINCE REVISION SURGERY. UPDATE: PATIENT HAD A REVISION DUE TO DISLOCATION ON (B)(6) 2022 & ON (B)(6) 2023. THIS PI IS FOR REVISION ON (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207819 | TRIDENT 0 DEG INSERT 40MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | 623-00-40G | V601RM | 07613327025361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Hospitalization| R |