MCK TIBIAL BASEPLATE-LM/RL-SZ 6
Report
- Report Number
- 3005985723-2023-00013
- Event Type
- Injury
- Date Received
- January 26, 2023
- Date of Event
- January 4, 2023
- Report Date
- June 30, 2023
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- NPJ
- UDI-DI
- 00848486000721
- PMA / PMN Number
- K090763
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
REPORTED EVENT: AN EVENT REGARDING CRACK/FRACTURE AND PERIPROSTHETIC FRACTURE INVOLVING A MAKO BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE AND CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS: "THE IMAGE DEPICTED SHOWS THE TIBIAL BASEPLATE WITH FRACTURE LOCATION HIGHLIGHTED. ALSO INCLUDED IN THE IMAGE ARE THE FEMORAL COMPONENT, THE TIBIAL INSERT AND A DETACHED PIECE OF THE TIBIAL BASEPLATE. ON VISUAL EXAMINATION, THE FRACTURE WAS OBSERVED LATERALLY THROUGH THE BASEPLATE. YELLOW DISCOLOURATION CONSISTENT WITH OXIDATION, POSSIBLY A RESULT OF SYNOVIAL FLUID ABSORPTION, WAS OBSERVED ON THE INSERT." MATERIAL ANALYSIS: A MATERIAL ANALYSIS WAS PERFORMED AND INDICATED THE FOLLOWING: "REVIEW OF TIBIAL BASEPLATE, CATALOGUE # 180606, LOT CODE 26030121-01 CONFIRMED FRACTURE OF THE BASEPLATE. CHARACTERISATION USING STEREO MICROSCOPY AND SCANNING ELECTRON MICROSCOPY CONFIRMED FRACTURE THROUGH THE BASEPLATE DUE TO A MIXTURE OF OVERLOAD AND FATIGUE.". -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: "THIS IS A CASE OF A PATIENT WHO UNDERWENT A PRIMARY MEDIAL COMPARTMENT PARTIAL KNEE ARTHROPLASTY WHO THEN DEVELOPED WITHIN TWO YEARS, A FRACTURE OF THE TIBIAL BASEPLATE NECESSITATING REVISION SURGERY. I CAN CONFIRM THAT THE PATIENT SUSTAINED THIS FRACTURE OF THE TIBIAL BASEPLATE SINCE I WAS ABLE TO REVIEW INTRAOPERATIVE X-RAYS SHOWING THE FRACTURE. I WAS ALSO ABLE TO REVIEW THE PRIMARY AND REVISION OPERATION NOTES SO I CAN CONFIRM THAT THOSE PROCEDURES OCCURRED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF BASEPLATE FRACTURE WITHIN TWO YEARS FOLLOWING PRIMARY SURGERY IS UNUSUAL AND MULTIFACTORIAL. THESE FACTORS INCLUDE SURGICAL FACTORS, SUCH AS SURGICAL TECHNIQUE, KNEE LIGAMENT BALANCING AND KINEMATICS, IMPLANT POSITIONING AND FIXATION, AS WELL AS PATIENT FACTORS INCLUDING ACTIVITY LEVEL AND BMI. IMPLANT FACTORS COULD BE CONSIDERED BUT IN ORDER TO DETERMINE THAT THE IMPLANT WOULD HAVE TO BE EXAMINED BY STRYKER ENGINEERS. UNTIL THAT OCCURS, I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT ITSELF. ADDENDUM: BASED UPON THE ADDITIONAL INFORMATION PROVIDED, THE X-RAY DOES SHOW A FRACTURE OF THE TIBIAL BASE PLATE WITH A METALLIC OBJECT POSTERIOR TO THE KNEE WITH A FRACTURE OF THE MEDIAL TIBIAL PLATEAU. THIS DOES NOT CHANGE MY ASSESSMENT. [...] ADDITIONALLY, THE PATIENT HAS PARKINSON¿S DISEASE, WHICH, IN AND OF ITSELF IS A RISK FACTOR FOR LOOSENING OF IMPLANTS. WHEN AN IMPLANT LOOSENS PREFERENTIALLY ON ONE SIDE, OR THE OTHER, FRACTURE OF THE IMPLANT CAN OCCUR BY CYCLIC LOADING. FURTHERMORE, THE PATIENT REPORTS A HISTORY OF MULTIPLE FALLS, WHICH DEFINITELY CAN CONTRIBUTE TO LOOSENING, AND CERTAINLY TO FRACTURE OF THE BASE PLATE.". -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE OF THE TIBIAL BASEPLATE AND PERIPROSTHETIC TIBIAL PLATEAU FRACTURE. A MATERIAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE AND INDICATED THE FOLLOWING: "ON VISUAL EXAMINATION, THE FRACTURE WAS OBSERVED LATERALLY THROUGH THE BASEPLATE. [...] CHARACTERISATION USING STEREO MICROSCOPY AND SCANNING ELECTRON MICROSCOPY CONFIRMED FRACTURE THROUGH THE BASEPLATE DUE TO A MIXTURE OF OVERLOAD AND FATIGUE." THE REPORTED EVENTS WERE ALSO CONFIRMED THROUGH CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS, BUT A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED: "CAUSES OF BASEPLATE FRACTURE WITHIN TWO YEARS FOLLOWING PRIMARY SURGERY IS UNUSUAL AND MULTIFACTORIAL. THESE FACTORS INCLUDE SURGICAL FACTORS, SUCH AS SURGICAL TECHNIQUE, KNEE LIGAMENT BALANCING AND KINEMATICS, IMPLANT POSITIONING AND FIXATION, AS WELL AS PATIENT FACTORS INCLUDING ACTIVITY LEVEL AND BMI. [...] ADDITIONALLY, THE PATIENT HAS PARKINSON¿S DISEASE, WHICH, IN AND OF ITSELF IS A RISK FACTOR FOR LOOSENING OF IMPLANTS. WHEN AN IMPLANT LOOSENS PREFERENTIALLY ON ONE SIDE, OR THE OTHER, FRACTURE OF THE IMPLANT CAN OCCUR BY CYCLIC LOADING. FURTHERMORE, THE PATIENT REPORTS A HISTORY OF MULTIPLE FALLS, WHICH DEFINITELY CAN CONTRIBUTE TO LOOSENING, AND CERTAINLY TO FRACTURE OF THE BASE PLATE." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED A RESTORIS LEFT MEDIAL PKA WAS REVISED DUE TO A BROKEN BASEPLATE (NO DIRECT CAUSE FOR BREAKAGE WAS REPORTED TO THE REP). PATIENT WAS CONVERTED TO A TKA WITH STEM AND AUGMENTS ON THE TIBIAL SIDE.
IT WAS REPORTED A RESTORIS LEFT MEDIAL PKA WAS REVISED DUE TO A BROKEN BASEPLATE (NO DIRECT CAUSE FOR BREAKAGE WAS REPORTED TO THE REP). PATIENT WAS CONVERTED TO A TKA WITH STEM AND AUGMENTS ON THE TIBIAL SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1175679 | MCK TIBIAL BASEPLATE-LM/RL-SZ 6 | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM | NPJ | MAKO SURGICAL CORP. | 180606 | 26030121-01 | 00848486000721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Hospitalization| R |