ROSA RECON PLATFORM 220V
Report
- Report Number
- 0009617840-2022-00016
- Event Type
- Injury
- Date Received
- April 4, 2022
- Date of Event
- October 10, 2021
- Report Date
- April 4, 2022
- Manufacturer
- ZIMMER CAS
- Product Code
- OLO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT: (B)(4). THIS PRODUCT IS SAME OR SIMILAR TO PMA/510(K) NUMBER: K182964. COUNTRY OF ORIGIN: (B)(6). THIS EVENT WAS PREVIOUSLY SUBMITTED ON NOV 8TH UNDER MFR REPORT: 0001822565-2021-03207. THE EVENT IS BEING RESUBMITTED UNDER THIS INITIAL REPORT TO CORRECT THE MFR NUMBER AND CORRESPONDING MANUFACTURING INFORMATION. UPDATED FIELDS FROM MFR: 0001822565-2021-03207. COUNTRY OF ORIGIN: (B)(6). ALL NECESSARY INFORMATION NEEDED FOR THE INVESTIGATION HAS BEEN PROVIDED AND AN INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
ZIMMER BIOMET COMPLAINT : (B)(4). THIS PRODUCT IS SAME OR SIMILAR TO PMA/510(K) NUMBER : K182964. COUNTRY OF ORIGIN : AUSTRALIA. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVALUATION SUMMARY THE ROBOTIC SYSTEM'S SOFTWARE APPLICATION LOG FILES AND PICTURES WERE SENT BACK FOR INVESTIGATION. INVESTIGATION OF THE LOG FILES CONFIRMED THE REPORTED EVENT OF RESECTION VALUE DISCREPANCY. IN THIS PARTICULAR CASE THE FOLLOWING POTENTIAL CAUSES ARE THE MOST PROBABLE: - MOVEMENT OF THE LEG, OR BONE TRACKER, RELATIVE TO THE CUT GUIDE DURING RESECTION - MOVEMENT OF THE ROBOT BASE OR ROBOT BASE TRACKER THE FUNCTIONALITY AND ACCURACY OF ROBOTIC SYSTEM WAS VERIFIED ON OCT 22, 2021 BY A FIELD SERVICE TECHNICIAN THROUGH THE FOLLOWING TESTS: - ROBOTIC ARM ACCURACY VERIFICATION - CAMERA ACCURACY VERIFICATION - ROBOTIC APPLICATIVE TEST ALL OF THE TESTS PASSED AND NO ISSUES RELATED TO THE REPORTED ISSUE WERE FOUND. THE REPORTED EVENT IS NOT CONSIDERED TO HAVE BEEN CAUSED BY MALFUNCTION OF THE ROBOTIC SYSTEM. A DHR REVIEW WAS PERFORMED AND INDICATED THAT THERE WAS NO ISSUE LINKED TO THE REPORTED EVENT. THE INSTRUMENTS ARE CONFIRMED TO HAVE MET SPECIFICATIONS AND WERE DETERMINED TO BE CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT PROBABLE CAUSES HAVE BEEN IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIAL RESECTIONS WERE AROUND 4-4.5 MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY (14MM) THAN PLANNED (10MM) WITH NO KNOWN REPORTED IMPACT TO THE PATIENT. PATIENT WAS PAIN FREE AND DISCHARGED 3 DAYS POST OP. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS INCIDENT.
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIAL RESECTIONS WERE AROUND 4-4.5 MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY (14MM) THAN PLANNED (10MM) WITH NO KNOWN REPORTED IMPACT TO THE PATIENT. PATIENT WAS PAIN FREE AND DISCHARGED 3 DAYS POST OP. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 604376 | ROSA RECON PLATFORM 220V | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | ZIMMER CAS | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |