SILKTOE SPACER
Report
- Report Number
- 3016669046-2026-00001
- Event Type
- Injury
- Date Received
- February 25, 2026
- Date of Event
- December 26, 2025
- Report Date
- April 2, 2026
- Manufacturer
- BRM EXTREMITIES S.R.L.
- Product Code
- KWH
- PMA / PMN Number
- K191966
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A POST-OPERATIVE INFECTION WAS REPORTED IN A PATIENT WHO HAD BEEN IMPLANTED WITH THE SILKTOE SPACER (SIZE 35 LEFT, LOT 0402/23) IN SINGAPORE. THE PATIENT REQUIRED MEDICAL TREATMENT FOR THE INFECTION. NO DEVICE MALFUNCTION, BREAKAGE, OR VISIBLE CONTAMINATION WAS REPORTED BY THE HEALTHCARE FACILITY. NO PACKAGING DAMAGE WAS OBSERVED AT THE TIME OF IMPLANTATION. A COMPREHENSIVE INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER IN ACCORDANCE WITH ITS POST-MARKET SURVEILLANCE AND VIGILANCE PROCEDURES. MANUFACTURING DOCUMENTATION FOR LOT 0402/23 WAS REVIEWED. THE RECORDS RELATING TO THE GROMMET WASHING, ENVELOPING AND PACKAGING PHASES OF THE DEVICE WERE VERIFIED AND FOUND TO BE IN LINE WITH EXPECTATIONS. AT THE END OF PACKAGING, IN ACCORDANCE WITH INTERNAL PROCEDURES, ONE PIECE WAS SAMPLED FOR BIOBURDEN ANALYSIS. THE RESULT OF THE ANALYSIS WAS <4 CFU/DEVICE, AS PER REPORT (B)(4). ALL IN-PROCESS AND FINAL INSPECTIONS MET SPECIFIED ACCEPTANCE CRITERIA. ENVIRONMENTAL MONITORING RESULTS DURING MANUFACTURING WERE WITHIN VALIDATED LIMITS. NO DEVIATIONS OR NON-CONFORMITIES WERE RECORDED DURING PRODUCTION. STERILIZATION REVIEW: STERILISATION BATCH RECORDS WERE REVIEWED AND VERIFIED. THE DEVICES WERE STERILIZED BY THE OUTSOURCER STERILVERONA ON 14-15 APRIL 2023, WITH BATCH NUMBER 23041501. ALL CYCLE PARAMETERS COMPLIED WITH VALIDATED STERILISATION REQUIREMENTS. BIOLOGICAL INDICATOR RESULTS MET ESTABLISHED STERILITY ASSURANCE CRITERIA AND NO STERILISATION DEVIATIONS OR ALARMS WERE RECORDED. COMPLAINT & TREND ANALYSIS: NO ADDITIONAL INFECTION COMPLAINTS HAVE BEEN REPORTED FOR LOT 0402/23. NO ADDITIONAL INFECTION COMPLAINTS HAVE BEEN REPORTED FOR THE SILKTOE SPACER DEVICE (INCLUDING LOT 0402/23) IN SINGAPORE OR GLOBALLY, SINCE 2017, THE DATE OF MARKET INTRODUCTION. FURTHERMORE, NO INFECTION-RELATED COMPLAINTS HAVE BEEN IDENTIFIED FOR OTHER DEVICES MANUFACTURED BY BRM EXTREMITIES OVER THE ENTIRE MARKETING PERIOD. NO ADVERSE TREND HAS BEEN IDENTIFIED FOR THE SILKTOE SPACER PRODUCT FAMILY. DEVICE AVAILABILITY: THE IMPLANTED DEVICE WAS NOT AVAILABLE FOR RETURN AND PHYSICAL EXAMINATION. ROOT CAUSE ASSESSMENT: BASED ON THE INVESTIGATION: NO EVIDENCE OF MANUFACTURING DEFECT WAS IDENTIFIED. NO STERILISATION FAILURE OR PACKAGING INTEGRITY ISSUE WAS IDENTIFIED. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVE INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH SURGICAL IMPLANTATION PROCEDURES AND IS REFLECTED IN THE DEVICE'S RISK MANAGEMENT DOCUMENTATION AND INSTRUCTIONS FOR USE. A DEFINITIVE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INFECTION COULD NOT BE ESTABLISHED. RISK ASSESSMENT: THE EVENT WAS ASSESSED IN ACCORDANCE WITH ISO 14971 RISK MANAGEMENT DOCUMENTATION: INFECTION IS AN IDENTIFIED HAZARD IN THE RISK MANAGEMENT FILE. EXISTING RISK CONTROLS (VALIDATED STERILISATION, CONTROLLED MANUFACTURING ENVIRONMENT, IFU WARNINGS) REMAIN EFFECTIVE. NO NEW RISKS OR INCREASED FREQUENCY TRENDS HAVE BEEN IDENTIFIED. THE OVERALL BENEFIT-RISK PROFILE OF THE DEVICE REMAINS FAVOURABLE. NO FIELD SAFETY CORRECTIVE ACTION (FSCA) IS REQUIRED. THE INVESTIGATION DID NOT IDENTIFY EVIDENCE OF A PRODUCT QUALITY ISSUE OR SYSTEMIC CONCERN RELATED TO LOT 0402/23. THE REPORTED INFECTION IS ASSESSED AS AN ISOLATED EVENT CONSISTENT WITH KNOWN SURGICAL RISKS ASSOCIATED WITH IMPLANTABLE MEDICAL DEVICES. NO FURTHER REGULATORY ACTION IS PROPOSED. FOLLOW UP REPORT (APRIL 2026): ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 (AND NOT IN (B)(6) 2026, AS PREVIOUSLY INDICATED). THE REPORT IS UPDATED TO ADDRESS THIS CHANGE. AS OF (B)(6) 2026, THE PATIENT HAD MADE A FULL RECOVERY.
A POST-OPERATIVE INFECTION WAS REPORTED IN A PATIENT WHO HAD BEEN IMPLANTED WITH THE SILKTOE SPACER (SIZE 35 LEFT, LOT: 0402/23) IN SINGAPORE. THE PATIENT REQUIRED MEDICAL TREATMENT FOR THE INFECTION. NO DEVICE MALFUNCTION, BREAKAGE, OR VISIBLE CONTAMINATION WAS REPORTED BY THE HEALTHCARE FACILITY. NO PACKAGING DAMAGE WAS OBSERVED AT THE TIME OF IMPLANTATION. A COMPREHENSIVE INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER IN ACCORDANCE WITH ITS POST-MARKET SURVEILLANCE AND VIGILANCE PROCEDURES. MANUFACTURING DOCUMENTATION FOR LOT: 0402/23 WAS REVIEWED. THE RECORDS RELATING TO THE GROMMET WASHING, ENVELOPING AND PACKAGING PHASES OF THE DEVICE WERE VERIFIED AND FOUND TO BE IN LINE WITH EXPECTATIONS. AT THE END OF PACKAGING, IN ACCORDANCE WITH INTERNAL PROCEDURES, ONE PIECE WAS SAMPLED FOR BIOBURDEN ANALYSIS. THE RESULT OF THE ANALYSIS WAS <4 CFU/DEVICE, AS PER REPORT (B)(4) (ANNEX 1). ALL IN-PROCESS AND FINAL INSPECTIONS MET SPECIFIED ACCEPTANCE CRITERIA. ENVIRONMENTAL MONITORING RESULTS DURING MANUFACTURING WERE WITHIN VALIDATED LIMITS. NO DEVIATIONS OR NON-CONFORMITIES WERE RECORDED DURING PRODUCTION. STERILIZATION REVIEW: STERILISATION BATCH RECORDS WERE REVIEWED AND VERIFIED. THE DEVICES WERE STERILIZED BY THE OUTSOURCER STERILVERONA ON 14-15 APRIL 2023, WITH BATCH NUMBER: 23041501. ALL CYCLE PARAMETERS COMPLIED WITH VALIDATED STERILISATION REQUIREMENTS. BIOLOGICAL INDICATOR RESULTS MET ESTABLISHED STERILITY ASSURANCE CRITERIA AND NO STERILISATION DEVIATIONS OR ALARMS WERE RECORDED. COMPLAINT & TREND ANALYSIS: NO ADDITIONAL INFECTION COMPLAINTS HAVE BEEN REPORTED FOR LOT: 0402/23. NO ADDITIONAL INFECTION COMPLAINTS HAVE BEEN REPORTED FOR THE SILKTOE SPACER DEVICE (INCLUDING LOT: 0402/23) IN SINGAPORE OR GLOBALLY, SINCE 2017, THE DATE OF MARKET INTRODUCTION. FURTHERMORE, NO INFECTION-RELATED COMPLAINTS HAVE BEEN IDENTIFIED FOR OTHER DEVICES MANUFACTURED BY BRM EXTREMITIES OVER THE ENTIRE MARKETING PERIOD. NO ADVERSE TREND HAS BEEN IDENTIFIED FOR THE SILKTOE SPACER PRODUCT FAMILY. DEVICE AVAILABILITY: THE IMPLANTED DEVICE WAS NOT AVAILABLE FOR RETURN AND PHYSICAL EXAMINATION. ROOT CAUSE ASSESSMENT: BASED ON THE INVESTIGATION: NO EVIDENCE OF MANUFACTURING DEFECT WAS IDENTIFIED. NO STERILISATION FAILURE OR PACKAGING INTEGRITY ISSUE WAS IDENTIFIED. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVE INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH SURGICAL IMPLANTATION PROCEDURES AND IS REFLECTED IN THE DEVICE'S RISK MANAGEMENT DOCUMENTATION AND INSTRUCTIONS FOR USE. A DEFINITIVE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INFECTION COULD NOT BE ESTABLISHED. RISK ASSESSMENT: THE EVENT WAS ASSESSED IN ACCORDANCE WITH ISO 14971 RISK MANAGEMENT DOCUMENTATION: INFECTION IS AN IDENTIFIED HAZARD IN THE RISK MANAGEMENT FILE. EXISTING RISK CONTROLS (VALIDATED STERILISATION, CONTROLLED MANUFACTURING ENVIRONMENT, IFU WARNINGS) REMAIN EFFECTIVE. NO NEW RISKS OR INCREASED FREQUENCY TRENDS HAVE BEEN IDENTIFIED. THE OVERALL BENEFIT-RISK PROFILE OF THE DEVICE REMAINS FAVOURABLE. NO FIELD SAFETY CORRECTIVE ACTION (FSCA) IS REQUIRED. THE INVESTIGATION DID NOT IDENTIFY EVIDENCE OF A PRODUCT QUALITY ISSUE OR SYSTEMIC CONCERN RELATED TO LOT: 0402/23. THE REPORTED INFECTION IS ASSESSED AS AN ISOLATED EVENT CONSISTENT WITH KNOWN SURGICAL RISKS ASSOCIATED WITH IMPLANTABLE MEDICAL DEVICES. NO FURTHER REGULATORY ACTION IS PROPOSED.
THIS IS A FOLLOW UP REPORT (APRIL 2026): THE EXPLANTATION DATE PREVIOUSLY COMMUNICATED WAS INCORRECT AND HAS BEEN CORRECTED TO (B)(6) 2025. AN ADVERSE EVENT INVOLVING WOUND BREAKDOWN AND PROSTHETIC JOINT INFECTION WAS REPORTED FOLLOWING IMPLANTATION OF THE SILKTOE 1ST MTPJ REPLACEMENT IN SINGAPORE. THE DEVICE WAS IMPLANTED ON (B)(6) 2025 AND THE ADVERSE EVENT TOOK PLACE ON (B)(6) 2025. THE EVENT WAS REPORTED BY THE TREATING SURGEON. THE PATIENT UNDERWENT REVISION SURGERY WITH REMOVAL OF THE SILKTOE IMPLANT ON (B)(6) 2025. THE EXPLANTED DEVICE WAS NOT AVAILABLE FOR RETURN OR FURTHER ANALYSIS. AS OF (B)(6) 2026, THE PATIENT HAD MADE A FULL RECOVERY. NO DEVICE-RELATED MALFUNCTION WAS IDENTIFIED.
AN ADVERSE EVENT INVOLVING WOUND BREAKDOWN AND PROSTHETIC JOINT INFECTION WAS REPORTED FOLLOWING IMPLANTATION OF THE SILKTOE 1ST MTPJ REPLACEMENT IN SINGAPORE. THE DEVICE WAS IMPLANTED ON (B)(6) 2025 AND THE ADVERSE EVENT TOOK PLACE ON DECEMBER 26TH 2025. THE EVENT WAS REPORTED BY THE TREATING SURGEON. THE PATIENT UNDERWENT REVISION SURGERY WITH REMOVAL OF THE SILKTOE IMPLANT ON (B)(6) 2026. THE EXPLANTED DEVICE WAS NOT AVAILABLE FOR RETURN OR FURTHER ANALYSIS. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT AND FOLLOW UP. NO DEVICE-RELATED MALFUNCTION WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451849 | SILKTOE SPACER | TOE JOINT POLYMER CONSTRAINED PROSTHESIS | KWH | BRM EXTREMITIES S.R.L. | 0402/23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Hospitalization| R |