SMARTSET GMV 40G US EO
Received Oct 29, 2025 · Event occurred Oct 6, 2025
Report 1818910-2025-18581 · MDR key 23419007
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Ireland - 3015516266Catalog number
545050501
Lot number
4682725
Product problems
- Loss of or Failure to Bond
- No Apparent Adverse Event
- Loss of or Failure to Bond
- No Apparent Adverse Event
Patient
58 YR · Male
- Unspecified Tissue Injury
- No Clinical Signs, Symptoms or Conditions
- Unspecified Tissue Injury
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION. DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED, NO INFORMATION PROVIDED. PROCEDURE RELATED, NO INFORMATION PROVIDED. DATE OF EVENT, AND THE DATE OF IMPLANT, NO INFORMATION PROVIDED. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: NO INFORMATION PROVIDED.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). 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.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.