UNKNOWN SOLAR ELBOW HUMERAL COMPONENT
Report
- Report Number
- 0002249697-2022-01574
- Event Type
- Injury
- Date Received
- October 31, 2022
- Date of Event
- January 12, 2015
- Report Date
- December 21, 2022
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
AN EVENT REGARDING REVISION INVOLVING AN UNKNOWN SOLAR HUMERAL COMPONENT WAS REPORTED. THE EVENT WAS NOT 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 INFORMATION BY A CLINICAL CONSULTANT INDICATED: "THIS PATIENT UNDERWENT A PRIMARY SOLAR TOTAL ELBOW PROSTHESIS WHICH FAILED AND SUBSEQUENTLY UNDERWENT A REVISION ALSO WITH A SOLAR TOTAL ELBOW PROSTHESIS. THIS REVISION IMPLANT ALSO FAILED AND ANOTHER REVISION IS CONTEMPLATED. THE ROOT CAUSE OF FAILURE OF THIS SECOND REVISION IMPLANT CANNOT BE DETERMINED WITH CERTAINTY. NOR CAN THE CAUSE OF THE PRIMARY SURGERY AND THE FIRST REVISION SURGERY BE DETERMINED. THERE IS NOT ENOUGH INFORMATION PROVIDED. I CAN CONFIRM THAT THE IMPLANT PLACED IN 2015 HAS FAILED DUE TO LOOSENING, OSTEOLYSIS AND DISASSOCIATION FROM THE BONE. THE ROOT CAUSE OF THIS TYPE OF FAILURE IS MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS, PATIENT FACTORS SUCH AS ACTIVITY LEVEL, BMI, AND HOST BONE INTEGRITY AND STRENGTH. AT THIS POINT IT DOES NOT APPEAR THAT ANY CAUSALITY OF THE FAILURE IS DUE TO THE IMPLANT ITSELF. GIVEN THE OBVIOUS RADIOLUCENCIES AND OSTEOLYSIS OF THE HUMERUS I BELIEVE IT WOULD WISE TO REPLACE IT RATHER THAN MATING IT WITH A NEW ULNAR COMPONENT." PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR AN UNKNOWN REASON. THE MEDICAL RECORDS PROVIDED ALSO DID NOT INDICATE THE REASON FOR REVISION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, RELEVANT PRE- AND POST-OPERATIVE X-RAYS AND THE REVISION 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. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT ELBOW IN 2015. IN FOLLOWING UP ON A PRODUCT INQUIRY REGARDING AN IMPENDING REVISION OF PATIENT'S RIGHT ELBOW, REP CONFIRMED THAT A REVISION IN 2015 WAS ALSO OF A SOLAR ELBOW. REASON FOR REVISION IS UNKNOWN AT THE TIME OF THIS REPORT.
THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT ELBOW IN 2015. IN FOLLOWING UP ON A PRODUCT INQUIRY REGARDING AN IMPENDING REVISION OF PATIENT'S RIGHT ELBOW, REP CONFIRMED THAT A REVISION IN 2015 WAS ALSO OF A SOLAR ELBOW. REASON FOR REVISION IS UNKNOWN AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1512084 | UNKNOWN SOLAR ELBOW HUMERAL COMPONENT | PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL | KWJ | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Hospitalization| R |