CMD 17-1277 HUMERAL IMPLANT
Report
- Report Number
- 3008021110-2022-00122
- Event Type
- Injury
- Date Received
- December 6, 2022
- Date of Event
- May 31, 2023
- Report Date
- December 4, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- JDB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE MANUFACTURING CHARTS WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS BELONGING TO THE LOT NUMBER INVOLVED. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.
THE MANUFACTURING CHARTS WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS BELONGING TO THE LOT NUMBER INVOLVED. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.
INVESTIGATION: THE MANUFACTURING CHARTS WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE CMD 17-1277 HUMERAL IMPLANT. THE COMPONENT REMOVED WAS NOT AVAILABLE TO BE RETURNED FOR FURTHER INVESTIGATION. HOWEVER, WE RECEIVED TWO X-RAYS TAKEN ON (B)(6) 2020, AND ONE X-RAY TAKEN ON (B)(6) 2022 AND WE SHARED THEM WITH OUR MEDICAL EXPERT. HIS EVALUATION IS REPORTED IN THE FOLLOWING STATEMENT: "THE RADIOGRAPHS IN 2020 LOOK FINE, I NOTICE A FOREARM DEFORMITY WITH THE RADIUS BOWED AND ABNORMAL ALIGNMENT IN RELATION TO THE ULNA AND THE ELBOW JOINT. I AGREE THAT THERE IS A HUMERAL COMPONENT LOOSENING ON THE RADIOGRAPHS IN 2022. THE REASON FOR THIS LOOSENING CAN BE NUMEROUS, IN THE END IT REMAINS UNCLEAR TO US WITHOUT FURTHER INFORMATION. A FATEFUL COURSE OF EVENTS IS LIKELY. I CANNOT OBSERVE A SPECIFIC IMPLANT-RELATED PROBLEM HERE." IT SHOULD BE TAKEN INTO ACCOUNT THAT, ACCORDING TO THE POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST VF190055, THE PATIENT SUFFERS FROM RIGHT ELBOW CONGENITAL CONTRACTURE (ELBOW STIFFNESS) AND RHEUMATOID ARTHRITIS RESULTING IN LONGSTANDING PAIN AND LIMITED RANGE OF MOTION. THEREFORE, BASED ON THE INFORMATION PROVIDED: - NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT BY CHECKING THE MANUFACTURING CHARTS OF THE CMD INVOLVED IN THE EVENT. - NO SPECIFIC IMPLANT-RELATED FAILURE IS VISIBLE, ACCORDING TO THE MEDICAL EXPERT'S ASSESSMENT. WE CAN CONCLUDE THAT THERE IS NO EVIDENCE OF IMPLANT RELATED ISSUE. PMS DATA: THE EVENT REPORTED BY COMPLAINT SOURCE IS LOOSENING OF A CUSTOM-MADE HUMERAL IMPLANT. NO REVISION RATE TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. NO CORRECTIVE ACTIONS ARE PLANNED FOR THIS CASE. LIMACORPORATE KEEPS MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE THIS IS THE FINAL DMR.
DISLOCATION OF CMD 17-1277 HUMERAL IMPLANT (PRODUCT CODE 9617.99.043, LOT NUMBER 1911366, STERILIZATION NUMBER 1900254) DISCOVERED ON (B)(6) 2022. ACCORDING TO THE INFORMATION GATHERED, "THERE IS ANTERIOR TILT OF THE HUMERAL COMPONENT, AND THE TIP ABUTS THE SHAFT WHERE THERE IS FOCAL CORTICAL REMODELING". THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. THE REVISION SURGERY IS GOING TO BE PLANNED. DURING THE REVISION SURGERY, THE COMPONENT DISLOCATED WILL BE REPLACED WITH CMD 22-1375. EVENT HAPPENED IN UNITED STATES.
DISLOCATION OF (B)(6) HUMERAL IMPLANT (PRODUCT CODE 9617.99.043, LOT NUMBER 1911366, STERILIZATION NUMBER 1900254) DISCOVERED ON SEPTEMBER 23RD, 2022. ACCORDING TO THE INFORMATION GATHERED, "THERE IS ANTERIOR TILT OF THE HUMERAL COMPONENT, AND THE TIP ABUTS THE SHAFT WHERE THERE IS FOCAL CORTICAL REMODELING".THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019.THE REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2023: THE COMPONENT DISLOCATED HAS BEEN REPLACED WITH (B)(6).DURING THE REVISION SURGERY, THE INSTRUMENTATION USED FAILED, AND THE AXLE PIN COULD NOT BE DISENGAGED FROM THE COMPONENTS. THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(6)AND REPORTED TO THE FDA AS MFR 3008021110-2023-00102.THE PATIENT IS A FEMALE, 62 YEARS OLD.EVENT HAPPENED IN UNITED STATES.
LOOSENING OF CMD 17-1277 HUMERAL IMPLANT (PRODUCT CODE 9617.99.043, LOT NUMBER 1911366, STERILIZATION NUMBER 1900254) DISCOVERED ON (B)(6) 2022. ACCORDING TO THE INFORMATION GATHERED, "THERE IS ANTERIOR TILT OF THE HUMERAL COMPONENT, AND THE TIP ABUTS THE SHAFT WHERE THERE IS FOCAL CORTICAL REMODELING". THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. THE CASE WAS REPORTED TO THE FDA THROUGH THE EXPANDED ACCESS PROGRAM (POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST VF190055). THE REVISION SURGERY HAS BEEN PERFORMED ON MAY 31ST ,2023: THE COMPONENT HAS BEEN REPLACED WITH CMD 22-1375. DURING THE REVISION SURGERY, THE INSTRUMENTATION USED FAILED, AND THE AXLE PIN COULD NOT BE DISENGAGED FROM THE COMPONENTS. THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT 275/23 AND REPORTED TO THE FDA AS MFR 3008021110-2023-00102. THE PATIENT IS A FEMALE, 62 YEARS OLD. EVENT HAPPENED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1853503 | CMD 17-1277 HUMERAL IMPLANT | CMD 17-1277 HUMERAL IMPLANT - CUSTOM MADE, | JDB | LIMACORPORATE S.P.A. | 9617.99.043 | 1911366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |