CMD 22-1105 HUMERAL IMPLANT
Report
- Report Number
- 3008021110-2023-00006
- Event Type
- Injury
- Date Received
- February 10, 2023
- Date of Event
- October 10, 2022
- Report Date
- May 7, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- JDB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION: THE MANUFACTURING CHARTS OF THE CMD 22-1105 HUMERAL IMPLANT INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. ACCORDING TO THE CASE REPORT OF THE CUSTOM-MADE IMPLANT CMD 22-1105, THE CUSTOMIZED HUMERAL COMPONENT IS SUPPOSED TO BE CEMENTLESS. FURTHERMORE, AS STATED IN LIMA CORPORATE IFU FOR PROMADE IMPLANTS, RE-USE OF PREVIOUSLY IMPLANTED DEVICES MUST BE ABSOLUTELY AVOIDED. RISKS ASSOCIATED WITH SINGLE USE DEVICES ARE INFECTION, EARLY OR LATE FAILURE OF THE DEVICE OR DEVICES FIXATION, LACK OF APPROPRIATE COUPLING BETWEEN MODULAR JUNCTIONS (E.G., TAPER CONNECTIONS), DEVICE WEAR AND WEAR DEBRIS ASSOCIATED COMPLICATIONS, TRANSMISSIONS OF DISEASES (E.G., HIV, HEPATITIS), IMMUNE SYSTEM RESPONSE/REJECTION. NO X-RAYS HAVE BEEN GATHERED BY THE COMPLAINT SOURCE. THEREFORE, IT IS IMPOSSIBLE TO EVALUATE THE STATUS OF THE IMPLANT AFTER THE REVISION SURGERY HEREBY REPORTED. BASED ON THE INFORMATION AND INVESTIGATION WE CAN CONSIDER THAT: THE MANUFACTURING CHARTS OF THE CMD 22-1105 HUMERAL IMPLANT INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. THE CUSTOMIZED HUMERAL COMPONENT RELATED TO THE CUSTOM-MADE IMPLANT CMD 22-1105 IS SUPPOSED TO BE CEMENTLESS, AND, AS STATED IN LIMA CORPORATE IFU FOR PROMADE IMPLANTS, RE-USE OF PREVIOUSLY IMPLANTED DEVICES MUST BE ABSOLUTELY AVOIDED. WE CAN SUPPOSE THIS EVENT WAS NOT IMPLANT RELATED. 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 MDR.
THE MANUFACTURING CHARTS OF THE CMD 22-1105 HUMERAL IMPLANT 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 22-1105 HUMERAL IMPLANT INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.
ELBOW REVISION SURGERY PERFORMED ON (B)(6), 2022, DUE TO LOOSENING. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. DURING THIS SURGERY THE PROMADE CMD 22-1105 HUMERAL IMPLANT (PRODUCT CODE 9617.25.30K, LOT NUMBER 2211499, STERILIZATION NUMBER 2200148) WAS IMPLANTED, TOGETHER WITH THE FOLLOWING COMPONENTS: CMD 22-1105 ULNAR STEM (PRODUCT CODE 9617.25.30L, LOT NUMBER 2211497, STERILIZATION NUMBER 2200142). TEMA ULNAR LINER LARGE (PRODUCT CODE 1560.50.020, LOT NUMBER 18AT1Q3, STERILIZATION NUMBER 1900225). TEMA ULNAR BODY LARGE (PRODUCT CODE 1552.14.020, LOT NUMBER 2206737, STERILIZATION NUMBER 2200121). TEMA ULNAR SAFETY SCREW (PRODUCT CODE 1552.15.900, LOT NUMBER 1813765, STERILIZATION NUMBER 1900303). SUBSEQUENTLY, SEVERAL DAYS AFTER THE SURGERY THE PATIENT WAS MOWING HIS LAWN ONE HANDED, AND THIS PROBABLY CAUSED THE LOOSENING OF THE IMPLANT. DURING THE ELBOW REVISION SURGERY HEREBY REPORTED, THE CMD 22-1105 HUMERAL IMPLANT WAS CEMENTED: THE IMPLANT WAS THOROUGHLY CLEANED AND PREPARED FOR LATER REINSERTION. THEN, THE HUMERAL COMPONENT WAS PLACED INTO THE HUMERUS AND HELD IN PLACE UNTIL THE CEMENT FULLY HARDENED. THE SURGEON DECIDED TO NOT REVISE THE ULNA. DURING THE ELBOW REVISION SURGERY ABOVE MENTIONED, NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 22-1105 HUMERAL IMPLANT. THE PATIENT INVOLVED HAS A COMPLEX CLINICAL HISTORY: ON (B)(6), 2022, INITIAL SURGERY PERFORMED ON (B)(6), 2022, IMPLANTING A TEMA ELBOW PROSTHESIS UNCEMENTED (OFF-LABEL USE). ON (B)(6) 2022, 1ST REVISION SURGERY PERFORMED DUE TO DISLOCATION. THIS REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR. 3008021110-2022-00047 ON (B)(6), 2022, 2ND REVISION SURGERY PERFORMED IMPLANTING THE CUSTOM-MADE COMPONENTS. ON (B)(6), 2022, 3RD REVISION SURGERY PERFORMED ON, DUE TO LOOSENING OF IMPLANT (HEREBY REPORTED). ON (B)(6), 2023, 4TH REVISION SURGERY PERFORMED DUE TO LOOSENING OF THE CUSTOM ULNAR COMPONENT. THIS REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH UNDER THE EXPANDED ACCESS PROGRAM (SEE POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST U220493). DURING THIS REVISION SURGERY, A T15 SCREWDRIVER SHAFT WAS FOUND BROKEN. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR. 3008021110-2023-00034. ON (B)(6), 2023, 5TH REVISION SURGERY WAS PERFORMED DUE TO SEPTIC LOOSENING OF IMPLANT. THIS REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR. 3008021110-2023-00094. PATIENT IS A 65-YEAR-OLD MALE WITH A HISTORY OF LEFT ELBOW RHEUMATOID/INFLAMMATORY ARTHRITIS. EVENT HAPPENED IN UNITED STATES.
ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO LOOSENING. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2022. DURING THIS SURGERY THE PROMADE CMD 22-1105 HUMERAL IMPLANT (PRODUCT CODE 9617.25.30K, LOT NUMBER 2211499, STERILIZATION NUMBER 2200148) WAS IMPLANTED, TOGETHER WITH THE FOLLOWING COMPONENTS: CMD 22-1105 ULNAR STEM (PRODUCT CODE 9617.25.30L, LOT NUMBER 2211497, STERILIZATION NUMBER 2200142). TEMA ULNAR LINER LARGE (PRODUCT CODE 1560.50.020, LOT NUMBER 18AT1Q3, STERILIZATION NUMBER 1900225). TEMA ULNAR BODY LARGE (PRODUCT CODE 1552.14.020, LOT NUMBER 2206737, STERILIZATION NUMBER 2200121). TEMA ULNAR SAFETY SCREW (PRODUCT CODE 1552.15.900, LOT NUMBER 1813765, STERILIZATION NUMBER 1900303). SUBSEQUENTLY, SEVERAL DAYS AFTER THE SURGERY THE PATIENT WAS MOWING HIS LAWN ONE HANDED, AND THIS PROBABLY CAUSED THE LOOSENING OF THE IMPLANT. DURING THE ELBOW REVISION SURGERY, THE CMD 22-1105 HUMERAL IMPLANT WAS CEMENTED: THE IMPLANT WAS THOROUGHLY CLEANED AND PREPARED FOR LATER REINSERTION. THEN, THE HUMERAL COMPONENT WAS PLACED INTO THE HUMERUS AND HELD IN PLACE UNTIL THE CEMENT FULLY HARDENED. THE SURGEON DECIDED TO NOT REVISE THE ULNA. DURING THE ELBOW REVISION SURGERY ABOVE MENTIONED, NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 22-1105 HUMERAL IMPLANT. THE CLINICAL HISTORY OF THE PATIENT IS THE FOLLOWING: SURGERY PERFORMED ON (B)(6), 2022, IMPLANTING A TEMA ELBOW PROSTHESIS UNCEMENTED (OFF-LABEL USE). REVISION SURGERY PERFORMED ON (B)(6), 2022, DUE TO DISLOCATION. THIS REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR 3008021110-2022-00047. SURGERY PERFORMED ON (B)(6), 2022, IMPLANTING THE CUSTOM MADE COMPONENTS. REVISION SURGERY PERFORMED ON (B)(6) 2022, HEREBY REPORTED. AFTER THE LAST FOLLOW UP THE PATIENT WENT ON HOLIDAY AND TOOK OFF SPLINT TO LIE ON BEACH. HE STATED AFTER THIS HE DEVELOPED WORSENING PROXIMAL FOREARM PAIN WITH SKIN DISCOLORATION. THE EXAMS SHOWED NO SIGNS OF INFECTION. DURING THE FOLLOW-UP VISIT PERFORMED ON (B)(6) ,2023, THE RADIOGRAPHS TAKEN SHOWED LOOSENING OF THE ULNAR COMPONENT WITH INTACT AXLE AND INTACT HUMERAL STEM. THE ULNAR IMPLANT WAS IN PLACE AND HAD NOT DISLODGED. THE REVISION SURGERY TO EXPLANT THE CMD 22-1105 HUMERAL IMPLANT WAS PERFORMED ON (B)(6) 2023. DURING THIS SURGERY, THE INSTRUMENT T15 SCREWDRIVER SHAFT (PRODUCT CODE 9015.90.005, LOT NUMBER 20BQ0D0) GOT BROKEN. THIS EVENT WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR 3008021110-2023- 00034. PATIENT IS A 65 YEAR-OLD MALE WITH A HISTORY OF LEFT ELBOW RHEUMATOID/INFLAMMATORY ARTHRITIS. EVENT HAPPENED IN US.
ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO LOOSENING. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. DURING THIS SURGERY THE PROMADE CMD 22-1105 HUMERAL IMPLANT (PRODUCT CODE: 9617.25.30K, LOT NUMBER: 2211499, STERILIZATION NUMBER: 2200148) WAS IMPLANTED, TOGETHER WITH THE FOLLOWING COMPONENTS: CMD 22-1105 ULNAR STEM (PRODUCT CODE: 9617.25.30L, LOT NUMBER: 2211497, STERILIZATION NUMBER: 2200142). TEMA ULNAR LINER LARGE (PRODUCT CODE: 1560.50.020, LOT NUMBER: 18AT1Q3, STERILIZATION NUMBER: 1900225). TEMA ULNAR BODY LARGE (PRODUCT CODE: 1552.14.020, LOT NUMBER: 2206737, STERILIZATION NUMBER: 2200121). TEMA ULNAR SAFETY SCREW (PRODUCT CODE 1552.15.900, LOT NUMBER: 1813765, STERILIZATION NUMBER: 1900303). SUBSEQUENTLY, SEVERAL DAYS AFTER THE SURGERY THE PATIENT WAS MOWING HIS LAWN ONE HANDED, AND THIS PROBABLY CAUSED THE LOOSENING OF THE IMPLANT. DURING THE ELBOW REVISION SURGERY, THE CMD 22-1105 HUMERAL IMPLANT WAS CEMENTED: THE IMPLANT WAS THOROUGHLY CLEANED AND PREPARED FOR LATER REINSERTION. THEN, THE HUMERAL COMPONENT WAS PLACED INTO THE HUMERUS AND HELD IN PLACE UNTIL THE CEMENT FULLY HARDENED. THE SURGEON DECIDED TO NOT REVISE THE ULNA. DURING THE ELBOW REVISION SURGERY ABOVE MENTIONED, NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 22-1105 HUMERAL IMPLANT. THE CLINICAL HISTORY OF THE PATIENT IS THE FOLLOWING: SURGERY PERFORMED ON (B)(6) 2022, IMPLANTING A TEMA ELBOW PROSTHESIS UNCEMENTED (OFF-LABEL USE). REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION. THIS REVISION SURGERY WAS REGISTERED WITH THE INTERNAL COMPLAINT: (B)(4) AND REPORTED WITH MFR 3008021110-2022-00047. SURGERY PERFORMED ON (B)(6) 2022, IMPLANTING THE CUSTOM MADE COMPONENTS. REVISION SURGERY PERFORMED ON (B)(6) 2022, HEREBY REPORTED. PATIENT IS A 64 YEAR-OLD MALE WITH A HISTORY OF LEFT ELBOW RHEUMATOID/INFLAMMATORY ARTHRITIS. EVENT HAPPENED IN US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48180 | CMD 22-1105 HUMERAL IMPLANT | CMD 22-1105 HUMERAL IMPLANT - CUSTOM MADE | JDB | LIMACORPORATE S.P.A. | 9617.25.30K | 2211499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |