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

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2021

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that during a tka surgery with rosa instrumentation, the planned distal femur cut was 7/9.5mm.The cut bone and validated cut was over resected at 10/12.5mm.There was no additional impact to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet(b)(4).This final report is being submitted to relay additional and/or corrected information.Sections b4, g3, g6, h2, and h10 were updated.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.

Event Description

It was reported that during a tka surgery with rosa instrumentation, the planned distal femur cut was 7/9.5mm.The cut bone and validated cut was over resected at 10/12.5mm.There was no additional impact to the patient.Attempts have been made and no further information has been provided.

• Brand Name: ROSA KNEE PLATFORM US PL B
• Type of Device: 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: 13257867
• MDR Text Key: 283948907
• Report Number: 0009617840-2022-00005
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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?: Yes
• Device Operator: 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
• Distributor Facility Aware Date: 12/28/2021
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male