CMD 16-1101 CUSTOM HUMERAL STEM
Report
- Report Number
- 3008021110-2023-00008
- Event Type
- Injury
- Date Received
- February 17, 2023
- Report Date
- March 20, 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 OF THE CMD 16-1101 CUSTOM HUMERAL STEM INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.
THE MANUFACTURING CHARTS OF THE CMD 16-1101 CUSTOM HUMERAL STEM INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE AVAILABLE. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; · THE MANUFACTURING CHARTS OF THE CMD 16-1101 CUSTOM HUMERAL STEM INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. · ACCORDING TO THE FOLLOW-UP NOTES RECEIVED BY THE COMPLAINT SOURCE, IN (B)(6) 2018 THE X-RAYS SHOWED RADIOLUCENCY CIRCUMFERENTIALLY AROUND THE HUMERUS AND FAILURE OF INGROWTH. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. THE EVENT REPORTED BY THE COMPLAINT SOURCE IS LOOSENING OF A CUSTOM-MADE HUMERAL STEM. NO REVISION RATE CAN 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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOWUP WILL BE SENT.
SECOND REVISION SURGERY TO BE PERFORMED, DUE TO LOOSENING. THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2018: DURING THIS SURGERY NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 16-1101 CUSTOM HUMERAL STEM (PRODUCT CODE 9617.99.013, LOT NUMBER 1615792, STERILIZATION NUMBER (B)(4)), IMPLANTED DURING THE PRIMARY SURGERY PERFORMED ON (B)(6) 2016. THIS FIRST REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR 3008021110-2023-00007. TWO YEARS LATER THE PATIENT HAD A FOLLOW UP NOTE FOR OLEACRANON BURSA OF THE ELBOW. THEREFORE, THE PROMADE (B)(4) WAS OPEN ON (B)(6) 2023, TO REVISE THE HUMERAL IMPLANT DUE TO LUCENCY AND AXLE BACKING OUT. THE REVISION SURGERY IS GOING TO BE PERFORMED. PATIENT IS A FEMALE, 39 YEARS OLD. EVENT HAPPENED IN US.
SECOND REVISION SURGERY TO BE PERFORMED, DUE TO LOOSENING. THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2018: DURING THIS SURGERY NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 16-1101 CUSTOM HUMERAL STEM (PRODUCT CODE 9617.99.013, LOT NUMBER 1615792, STERILIZATION NUMBER (B)(4)), IMPLANTED DURING THE PRIMARY SURGERY PERFORMED ON (B)(6) 2016. THIS FIRST REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR 3008021110-2023-00007. TWO YEARS LATER THE PATIENT HAD A FOLLOW UP NOTE FOR OLECRANON BURSA OF THE ELBOW. THEREFORE, THE PROMADE (B)(4) WAS OPEN ON (B)(6) 2023, TO REVISE THE HUMERAL IMPLANT DUE TO LUCENCY AND AXLE BACKING OUT. THE REVISION SURGERY IS GOING TO BE PERFORMED. PATIENT IS A FEMALE, 39 YEARS OLD. EVENT HAPPENED IN US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110296 | CMD 16-1101 CUSTOM HUMERAL STEM | CMD 16-1101 CUSTOM HUMERAL STEM | JDB | LIMACORPORATE S.P.A | 9617.99.013 | 1615792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention| O |