REAL INTELLIGENCE CORI
Report
- Report Number
- 1020279-2024-00393
- Event Type
- Injury
- Date Received
- February 19, 2024
- Date of Event
- February 5, 2024
- Report Date
- October 15, 2025
- Manufacturer
- BLUE BELT TECHNOLOGIES, INC.
- Product Code
- OLO
- UDI-DI
- 00885556757420
- PMA / PMN Number
- K193120
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INTERNAL COMPLAINT REFERENCE: (B)(4).
SECTION H6 WAS UPDATED. SECTION H10 (UPDATE RESULTS OF INVESTIGATION): THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER (B)(6), INTENDED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE A DEVICE ANALYSIS WAS UNABLE TO BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED WITHIN THE ECRFS, DEFINITIVE CONTRIBUTING CLINICAL FACTORS CANNOT BE CONCLUDED; HOWEVER, IT IS UNKNOWN IF THE AE#1 (PAIN) MAY HAVE CONTRIBUTED TO THE REPORTED AE#2 (STIFFNESS/LIMITED FLEXION) AT SIX-WEEKS POST-OP, THEREFORE, CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. ADDITIONALLY, IT IS NOTED IN THE ECRF SURGICAL SUMMARY/INSTRUMENT USE THAT THE POROUS TKA PROCEDURE INCORPORATED THE CORI SYSTEM, AND THEREFORE WOULD BE CATEGORIZED AS AN OFF-LABEL USE OF THE CORI SYSTEM. THE PATIENT IMPACT BEYOND THE REPORTED RIGHT KNEE PAIN AND STIFFNESS/LIMITED FLEXION FOLLOWING THE OFF-LABEL CORI PROCEDURE WITH PRESCRIBED INTERVENTIONS: MEDICINE (AE#1,AE#2) AND PHYSICAL THERAPY (AE#2) CANNOT BE DETERMINED WITH CERTAINTY. PER ECRFS, OUTCOME IS ¿RECOVERING/RESOLVING¿. SYSTEM LOG FILES OR SCREENSHOTS WERE NOT PROVIDED FOR INVESTIGATION, AS SUCH A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. SHOULD SCREENSHOTS OR SYSTEM LOG FILES BECOME AVAILABLE, THE CASE CAN BE REOPENED. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. AS WITH ANY SURGICAL PROCEDURE, THERE IS RISK INVOLVED. POTENTIAL COMPLICATIONS ACCOMPANYING SURGERY MAY OCCUR, INCLUDING: ALLERGIC REACTION (ANAPHYLACTIC AND MINOR), INFECTION, MILD TO SERIOUS PHYSICAL INJURY, LOCALIZED STATIC SHOCK, DELAY IN THE OPERATION, SURGICAL SITE NERVE INJURY, VASCULAR INJURIES OF THE LOWER EXTREMITY, SOFT TISSUE DAMAGE, MAJOR BONE GOUGING AT THE SURGICAL SITE, BONE FRACTURE, IMMATURE IMPLANT FAILURE, UNSTABLE KNEE JOINT, LIMITED OR RESTRICTED KNEE RANGE OF MOTION, MAJOR BLUNT IMPACT INJURY, UNINTENDED LACERATION/PUNCTURE WOUND, AND OSTEONECROSIS. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL ESCALATION EVENT REVIEW WAS NOT COMPLETED. THE PRODUCT WAS NOT RETURNED AND NO EVIDENCE WAS MADE AVAILABLE TO LINK THE COMPLAINT TO AN ESCALATION EVENT. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. NO REASONABLE CAUSE COULD BE IDENTIFIED BASED ON THE RECEIVED COMPLAINT INFORMATION AND INVESTIGATION RESULTS. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.
B5: EVENT DESCRIPTION. D1, D2A, D2B: BRAND NAME, PRODUC CODE. D3: MANUFACTURER INFORMATION. D4: DEVICE INFORMATION. D10: CONCOMITANT DEVICES. G: MANUFACTURING SITE OFFICE CONTACT. G4: 510K. THE CORRECT MANUFACTURER REPORT NUMBER IS 3010266064.
D4: SERIAL NUMBER.
SECTION D10 AND H6 WERE UPDATED, SECTION H10: GIVEN THE NATURE OF THE ALLEGED INCIDENT, THE DEVICES COULD NOT BE RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT THE ADVERSE EVENT #1 (PAIN) WAS DEEMED UNRELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE PER THE ELECTRONIC CLINICAL REPORT FORMS (SAFETY NOTIFICATION TRACKER) WITH MEDICATION START/STOP DATE DOCUMENTED AS (B)(6) 2023 ENDING ON (B)(6) 2024. ADVERSE EVENT #2 (LIMITED FLEXION) WAS DEEMED POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE WITH MEDICATION START DATE BEING (B)(6) 2024 WITH ADJUNCTIVE PHYSICAL THERAPY AND DOCUMENTED AS RECOVERING/RESOLVING WITH CAUSAL RELATIONSHIP TO STUDY DEVICE/PROCEDURE AS OF THE (B)(6) 2024. BASED ON THE INFORMATION PROVIDED WITHIN THE ELECTRONIC CLINICAL REPORT FORMS, DEFINITIVE CONTRIBUTING CLINICALLY FACTORS CANNOT BE CONCLUDED; HOWEVER, IT IS UNKNOWN IF THE PAIN MAY HAVE CONTRIBUTED TO THE REPORTED STIFFNESS/LIMITED FLEXION AT SIX-WEEKS POST-OP, THEREFORE, CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THE PATIENT IMPACT BEYOND THE REPORTED RIGHT KNEE PAIN AND STIFFNESS/LIMITED FLEXION WITH PRESCRIBED INTERVENTIONS (MEDICINE AND PHYSICAL THERAPY) CANNOT BE DETERMINED. PER ELECTRONIC CLINICAL REPORT FORMS, OUTCOME IS ¿RECOVERING/RESOLVING¿. A REVIEW OF THE PRODUCTION ORDERS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. FOR THE FEMORAL COMPONENT AND THE TIBIAL BASEPLATE, A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. FOR THE INSERT, A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. FOR THE PATELLA, A REVIEW OF COMPLAINT HISTORY BASED ON THE HISTORICAL DATA REVEALED A SIMILAR EVENT FOR THE LISTED BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR KNEE SYSTEMS REVEALED THAT POSTOPERATIVE PATIENT CARE AND DIRECTIONS AND WARNINGS TO PATIENTS BY PHYSICIANS ARE EXTREMELY IMPORTANT. PROTECTED WEIGHT BEARING WITH EXTERNAL SUPPORT IS RECOMMENDED FOR A PERIOD OF TIME TO ALLOW HEALING. NORMAL DAILY ACTIVITY MAY BE RESUMED AT THE PHYSICIAN¿S DIRECTION. ALSO, WARNINGS AND PRECAUTIONS STATES THAT THE PATIENT SHOULD BE WARNED OF SURGICAL RISKS, AND MADE AWARE OF POSSIBLE ADVERSE EFFECTS. THE PATIENT SHOULD BE WARNED THAT THE IMPLANT CAN BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA. BESIDES, POSSIBLE ADVERSE EFFECTS SECTION STATES THAT TEMPORARY OR PERMANENT NERVE DAMAGE CAN RESULT IN PAIN OR NUMBNESS OF THE AFFECTED LIMB. LASTLY, REVEALED THAT DECREASED RANGE OF MOTION AND UNUSUAL STRESS CONCENTRATIONS CAN RESULT FROM TRAUMA, IMPROPER IMPLANT SELECTION, IMPROPER IMPLANT POSITIONING, IMPROPER FIXATION, AND/OR MIGRATION OF THE COMPONENTS. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. A REVIEW OF THE RISK MANAGEMENT FILES REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THESE PRODUCTS AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE TRAUMATIC INJURY, ALIGNMENT, SIZE SELECTED, WEAR, PATIENT CONDITION OR POSTOPERATIVE CARE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. INTERNAL COMPLAINT REFERENCE NUMBER: CASE (B)(4).
SECTION H6 WAS UPDATED, SECTION H10: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER UNKNOWN, INTENDED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE A DEVICE ANALYSIS WAS UNABLE TO BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED WITHIN THE ECRFS, DEFINITIVE CONTRIBUTING CLINICAL FACTORS CANNOT BE CONCLUDED; HOWEVER, IT IS UNKNOWN IF THE AE#1 (PAIN) MAY HAVE CONTRIBUTED TO THE REPORTED AE#2 (STIFFNESS/LIMITED FLEXION) AT SIX-WEEKS POST-OP, THEREFORE, CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. ADDITIONALLY, IT IS NOTED IN THE ECRF SURGICAL SUMMARY/INSTRUMENT USE THAT THE POROUS TKA PROCEDURE INCORPORATED THE CORI SYSTEM, AND THEREFORE WOULD BE CATEGORIZED AS AN OFF-LABEL USE OF THE CORI SYSTEM. THE PATIENT IMPACT BEYOND THE REPORTED RIGHT KNEE PAIN AND STIFFNESS/LIMITED FLEXION FOLLOWING THE OFF-LABEL CORI PROCEDURE WITH PRESCRIBED INTERVENTIONS: MEDICINE (AE#1,AE#2) AND PHYSICAL THERAPY (AE#2) CANNOT BE DETERMINED WITH CERTAINTY. PER ECRFS, OUTCOME IS ¿RECOVERING/RESOLVING¿. SYSTEM LOG FILES OR SCREENSHOTS WERE NOT PROVIDED FOR INVESTIGATION, AS SUCH A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. SHOULD SCREENSHOTS OR SYSTEM LOG FILES BECOME AVAILABLE, THE CASE CAN BE REOPENED. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. WHILE ALL PRODUCTS MEET REQUIRED MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE A SERIAL NUMBER, LOT NUMBER, PART REVISION OR SOFTWARE VERSION IS REQUIRED TO LINK THE DEVICE TO A DHR OR NC INVESTIGATION. AS WITH ANY SURGICAL PROCEDURE, THERE IS RISK INVOLVED. POTENTIAL COMPLICATIONS ACCOMPANYING SURGERY MAY OCCUR, INCLUDING: ALLERGIC REACTION (ANAPHYLACTIC AND MINOR), INFECTION, MILD TO SERIOUS PHYSICAL INJURY, LOCALIZED STATIC SHOCK, DELAY IN THE OPERATION, SURGICAL SITE NERVE INJURY, VASCULAR INJURIES OF THE LOWER EXTREMITY, SOFT TISSUE DAMAGE, MAJOR BONE GOUGING AT THE SURGICAL SITE, BONE FRACTURE, IMMATURE IMPLANT FAILURE, UNSTABLE KNEE JOINT, LIMITED OR RESTRICTED KNEE RANGE OF MOTION, MAJOR BLUNT IMPACT INJURY, UNINTENDED LACERATION/PUNCTURE WOUND, AND OSTEONECROSIS. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL ESCALATION EVENT REVIEW WAS NOT COMPLETED. THE PRODUCT WAS NOT RETURNED AND NO EVIDENCE WAS MADE AVAILABLE TO LINK THE COMPLAINT TO AN ESCALATION EVENT. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. NO REASONABLE CAUSE COULD BE IDENTIFIED BASED ON THE RECEIVED COMPLAINT INFORMATION AND INVESTIGATION RESULTS. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT, AFTER A RIGHT TKA PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN ONE (1) WEEK POST-OP, AND STIFFNESS/ LIMITED FLEXION SIX (6) WEEKS POST OP ON (B)(6) 2024. BOTH ADVERSE EVENTS HAVE BEEN TREATED WITH MEDICATIONS (ETORICOXIB) AND PHYSICAL THERAPY. THE PATIENT IS CURRENTLY RECOVERING. NO OTHER COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT, AFTER A RIGHT CORI ASSISTED TKA PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN ONE (1) WEEK POST-OP, AND STIFFNESS/ LIMITED FLEXION SIX (6) WEEKS POST OP ON (B)(6) 2024. THIS ADVERSE EVENT IS POSSIBLY RELATED TO THE STUDY PROCEDURE. BOTH ADVERSE EVENTS HAVE BEEN TREATED WITH MEDICATIONS (ETORICOXIB) AND PHYSICAL THERAPY. THE PATIENT IS CURRENTLY RECOVERING. NO OTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416830 | REAL INTELLIGENCE CORI | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | BLUE BELT TECHNOLOGIES, INC. | 20LHA0031D | 00885556757420 | |
| 925768 | REAL INTELLIGENCE CORI | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | BLUE BELT TECHNOLOGIES, INC. | 20LHA0031D | 00885556757420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | PN: 71425215 / LOT: 20LHA0031D| PN: 71425304 / LOT: 22DM05266| PN: 71425304/ LN: 22DM05266| PN: 71425339 / LOT: 21LM08699| PN: 71425339/ LN: 21LM08699| PN: 74027432 / LOT: 22BM19430| PN: 74027432/ LN: 22BM19430 |