REAL INTELLIGENCE CORI
Report
- Report Number
- 1020279-2024-00051
- Event Type
- Injury
- Date Received
- January 8, 2024
- Date of Event
- December 8, 2023
- Report Date
- May 29, 2024
- Manufacturer
- BLUE BELT TECHNOLOGIES, INC.
- Product Code
- OLO
- PMA / PMN Number
- K193120
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). RESULTS OF INVESTIGATION: 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 STATED THAT PATIENT-SPECIFIC CLINICAL DOCUMENTATION HAD NOT BEEN PROVIDED; THEREFORE, THE DEFINITIVE CLINICAL ROOT CAUSE FOR THE ADVERSE EVENT COULD NOT BE DETERMINED. THE CASE REPORT FORMS PROVIDED WERE USED FOR THIS INVESTIGATION. ACCORDING TO THE REPORT, THE PATIENT WAS TREATED WITH MORPHINE AND MIDAZOLAM. POST-OPERATIVE PAIN IS A KNOWN COMMON OCCURRENCE, AS PART OF THE HEALING PROCESS IN THE IMMEDIATE POST-OPERATIVE PERIOD. THE IMPACT TO THE PATIENT WAS THE REPORTED LEFT KNEE PAIN AND THE MEDICATIONS. SINCE IT WAS REPORTED THAT THE ADVERSE EVENT WAS RESOLVED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. A REVIEW OF THE PRODUCTION ORDERS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE FEMORAL COMPONENT AND TIBIAL BASEPLATE PART NUMBERS OVER THE PAST 12 MONTHS AND FOR THEIR BATCH NUMBERS BASED ON HISTORICAL DATA OF THE DEVICES DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICES. A REVIEW OF COMPLAINT HISTORY BASED ON THE HISTORICAL DATA REVEALED A SIMILAR EVENT FOR THE INSERT'S BATCH. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE PATELLA 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. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR KNEE SYSTEMS REVEALED THAT TEMPORARY OR PERMANENT NERVE DAMAGE CAN RESULT IN PAIN OR NUMBNESS OF THE AFFECTED LIMB. THIS HAS BEEN IDENTIFIED AS A POSSIBLE ADVERSE EFFECT. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. 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, JOINT TIGHTNESS, 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. WE CONSIDER THIS INVESTIGATION CLOSED. CORRECTED DATA: H6 (HEALTH EFFECT - CLINICAL CODE).
H10: INTERNAL COMPLAINT REFERENCE (B)(4).
SECTION H6 WAS UPDATED. SECTION H10 (UPDATED RESULTS OF INVESTIGATION): THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER UNKNOWN, USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE A DEVICE ANALYSIS WAS UNABLE TO BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT AS OF THE DATE OF THIS MEDICAL INVESTIGATION, PATIENT-SPECIFIC CLINICAL DOCUMENTATION HAS NOT BEEN PROVIDED; THEREFORE, THE DEFINITIVE CLINICAL ROOT CAUSE FOR THE ADVERSE EVENT COULD NOT BE DETERMINED. THE ECRF PROVIDED WERE USED FOR THIS INVESTIGATION. ACCORDING TO THE REPORT, THE PATIENT¿S LEFT KNEE PAIN WAS TREATED WITH MORPHINE AND MIDAZOLAM. THE IFU FOR KNEE SYSTEMS 81074901 REV. B., REVEALED IN POSSIBLE ADVERSE EFFECTS THAT TEMPORARY OR PERMANENT NERVE DAMAGE CAN RESULT IN PAIN OR NUMBNESS OF THE AFFECTED LIMB. POST-OPERATIVE PAIN IS A KNOWN COMMON OCCURRENCE, AS PART OF THE HEALING PROCESS IN THE IMMEDIATE POST-OPERATIVE PERIOD. OF NOTE, THE POROUS TKA PROCEDURE INCORPORATED THE USE OF THE CORI SYSTEM, THEREFORE, THIS WOULD BE CATEGORIZED AS AN OFF-LABEL USE OF THE CORI SYSTEM SINCE THE USE OF CORI ISN¿T SET UP FOR THE CEMENT-LESS COMPONENTS THIS CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE ADVERSE EVENT. THE IMPACT TO THE PATIENT WAS THE REPORTED OFF LABEL USE, LEFT KNEE PAIN, PROLONGED HOSPITALIZATION, AND THE MEDICATIONS. SINCE IT WAS REPORTED THE ADVERSE EVENT WAS RESOLVED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE PROVIDED, THIS CASE WOULD BE REOPENED. 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 REVIEW OF COMPLAINT HISTORY OF THE PREVIOUS 3 YEARS FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. 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).
H11- CORRECTED DATA: B5- DESCRIBE EVENT OR PROBLEM. D3- MANUFACTURER NAME, CITY AND STATE: THIS REPORT WAS INADVERTENTLY SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1020279. CORRECT MANUFACTURER REPORT NUMBER IS 3010266064. D4- CATALOG NUMBER, UNIQUE IDENTIFIER (UDI) #. D6A / D6B ¿ NOT APPLICABLE. D10- CONCOMITANT MEDICAL PRODUCTS. G- CONTACT OFFICE - MANUFACTURING SITE. G4- PMA/510(K)NUMBER. H8- USAGE OF DEVICE.
IT WAS REPORTED THAT, AFTER A POROUS TKA SYSTEM HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED SEVERE LEFT KNEE PAIN. THE PATIENT REQUIRED TWO (2) ADDITIONAL, UNPLANNED DAYS IN THE HOSPITAL AND RECEIVED TREATMENT IN THE FORM OF MEDICATION (MORFINE, MIDOZOLAM). THE ISSUE HAS BEEN RESOLVED.
IT WAS REPORTED THAT, DURING A TKA SURGERY PERFORMED ON (B)(6) 2023 WHERE AN UNCEMENTED SYSTEM WAS PLACED, THE REAL INTELLIGENCE CORI CONSOLE WAS USED OFF-LABEL, AS IT IS INDICATED FOR CEMENTED IMPLANTS ONLY. AFTER THE SURGERY, THE PATIENT EXPERIENCED SEVERE LEFT KNEE PAIN. THIS CONDITION WAS RESOLVED AFTER TWO ADDITIONAL, UNPLANNED DAYS IN THE HOSPITAL, DURING WHICH THE PATIENT RECEIVED TREATMENT IN THE FORM OF MEDICATION (MORFINE, MIDOZOLAM).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1383621 | REAL INTELLIGENCE CORI | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | BLUE BELT TECHNOLOGIES, INC. | 20HHA0015 | ||
| 949132 | REAL INTELLIGENCE CORI | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | BLUE BELT TECHNOLOGIES, INC. | 20HHA0015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention| H | LGN CR XLP INS SZ5-6 9MM(PN:71425346,LN:21LM04251)| LGN CR XLP INS SZ5-6 9MM(PN:71425346,LN:21LM04251)| LGN PR CR HA FEM SZ7 LT(PN:71425207,20HHA0015)| PRS OV PATELLA SZ 32MM(PN:74027432,LN:22BM19430)| PRS OV PATELLA SZ 32MM(PN:74027432,LN:22BM19430)| PRS TIB BSPLT SZ6 LT(PN:71425326,LN:22EM05861)| PRS TIB BSPLT SZ6 LT(PN:71425326,LN:22EM05861) |