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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER BIOMET, INC. ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2021
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint : (b)(4). This product is same or similar to pma/510(k) number : k182964. 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.
 
Event Description
It was reported that a patient underwent a 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.
 
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Brand NameROSA RECON PLATFORM 220V
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12770770
MDR Text Key280462602
Report Number0001822565-2021-03207
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-100-26
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/08/2021 Patient Sequence Number: 1
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