UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA
Report
- Report Number
- 8030965-2024-00890
- Event Type
- Injury
- Date Received
- January 16, 2024
- Date of Event
- June 1, 2023
- Report Date
- January 16, 2024
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YOSHIDA, S. ET AL (2023), KNEE ALIGNMENT CORRECTION BY HIGH TIBIAL OSTEOTOMY REDUCES SYMPTOMS AND SYNOVIAL INFLAMMATION IN KNEE OSTEOARTHRITIS ACCOMPANIED BY MACROPHAGE PHENOTYPIC CHANGE FROM M1 TO M2, ARTHRITIS & RHEUMATOLOGY, VOL. 75 (6), PAGES 950¿960 (JAPAN). THIS STUDY AIMED TO DETERMINE WHETHER ALIGNMENT CORRECTION BY HIGH TIBIAL OSTEOTOMY (HTO) CAN CHANGE THE BIOLOGIC INTRAARTICULAR MICROENVIRONMENT OF OSTEOARTHRITIC (OA) KNEES. BETWEEN (B)(6) 2020, A TOTAL OF 40 CONSECUTIVE PATIENTS WHO UNDERWENT MEDIAL OPEN-WEDGE HTO WERE INITIALLY INCLUDED IN THE STUDY. TWO OSFERION60 -TRICALCIUM PHOSPHATE WEDGE SPACERS (OLYMPUS-TERUMO BIOMATERIALS) WERE INSERTED INTO THE GAP, AND THE OSTEOTOMY WAS FIXED WITH TOMOFIX MEDIAL HIGH TIBIAL PLATE (DEPUY SYNTHES). AMONG THESE, 9 WERE EXCLUDED, WITH A FINAL NUMBER OF 31 PATIENTS (19 WERE FEMALE; MEAN AGE OF 61.1 7.5 YEARS) INCLUDED IN THE ANALYSIS. SYNOVIAL TISSUE (ST) AND FLUID (SF) WERE COLLECTED FROM THE AFFECTED KNEES OF THESE PATIENTS DURING INITIAL HTO AND PLATE REMOVAL SURGERIES. THE FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN 5 PATIENTS WHO WERE EXCLUDED FROM THE ANALYSIS, OSTEONECROSIS OCCURRED. IN 1 PATIENT WHO WAS EXCLUDED FROM THE ANALYSIS, A SURGICAL SITE INFECTION OCCURRED WHICH REQUIRED ADDITIONAL SURGERY. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATE/SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1677479 | UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA | PLATE, FIXATION, BONE | HRS | SYNTHES GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |