MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM GB PL G; INSTRUMENT, KNEE

Model Number N/A

Device Problems Incorrect Measurement (1383); Output Problem (3005); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age: (b)(6).Report source: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is remains at the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the planned outcome and validated cut showed 0 degrees varus/valgus.However, post-op x-rays show a grade 2 valgus.It was noted that the patient was varus pre-op.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Independent assessment of the post op images confirms the reported event.However, the assessment revealed a grade 1 valgus measured at 5 degrees (grade 1 < 10 degrees).The femoral and tibial components relative to the mechanical axis were 92 and 94 degrees, respectively.The rosa knee system software application log files were sent back for investigation.Investigation of the log files by a software sme revealed the following: no registration fails were encountered during landmarking of the image based case, thus indicating that landmark acquisition was performed correctly; cut validation values were close to 0 degrees (femur 0.2varus, tibia 0.4varus) and correspond to the intra-operatively planned cuts; final knee state in extension was symmetrical at around 0 degree hka.Furthermore, the rosa knee system was assessed for robotic arm accuracy, camera accuracy and applicative test and found to be accurate and functional.The dhr was reviewed and no discrepancies relevant to the reported event were found.Investigation confirmed that the rosa knee system was conforming to specifications as no issues were found during the evaluation.Additionally, no issues were identified during the log files investigation.Therefore, the reported event is not considered to have been caused by a malfunction of the rosa knee system.A definitive root cause could not be determined.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.

• Brand Name: ROSA KNEE PLATFORM GB PL G
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• MDR Report Key: 9632853
• MDR Text Key: 189995556
• Report Number: 0009617840-2020-00001
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00889024511286
• UDI-Public: 0889024511286
• Combination Product (y/n): N
• PMA/PMN Number: K19074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-12
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other