MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM US PL B; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a robotic assisted tka the tibia was over resected by 3 mm.Due to this discrepancy, a 16mm poly insert was used instead of the planned 13mm insert.No additional patient impact has been reported other than the deviation from planned implant size.Attempts have been made and no further information has been provided at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The rosa knee system log files were sent back for investigation and analyzed by a subject matter expert (sme).The logs do not allow to confirm which poly size was used, however the two validations of the tibia confirmed the reported over-resection.The functionality and accuracy of rosa knee platform was verified by a field service engineer (fse).The fse did not find anything off with the system.Review of dhr identified no deviations or anomalies related to the reported event.A definitive root cause could not be determined with the information available.Through reassessment of this event, it was identified as being reported in error.Reportability is based on harm/intervention required and not a specific resection level.No patient impact, medical intervention, or surgical intervention was reported for this event; therefore, the event does not meet the requirements for a serious injury/adverse event and is considered not reportable.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information on the reported event.

• Brand Name: ROSA KNEE PLATFORM US PL B
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13862067
• Report Number: 0009617840-2022-00011
• Device Sequence Number: 12086183
• Product Code: OLO
• UDI-Device Identifier: 00889024511026
• UDI-Public: (01)00889024511026(11)200612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female