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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE TIBIAL CUT GUIDE 5 DEGREES; INSTRUMENT, KNEE
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ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE TIBIAL CUT GUIDE 5 DEGREES; INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  malfunction  
Event Description
It was reported that during a partial knee arthroplasty, the drill pin became jammed in the tibial cut guide.The procedure was completed utilizing another device.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
(b)(4).Concomitant medical products: medical devices: nexgen headless trocar drill pin 3.2mm diameter 75mm length catalog #: 00590102000.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
 
Manufacturer Narrative
This follow-up report is being filed to correct information.Upon reassessment of the reported event, it was identified that the previous report submitted on jul 28, 2022 was submitted erroneously.The reported event will be investigated and submitted under 0001822565-2022-01551.
 
Event Description
No further event information available at the time of this report.
 
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 and corrected information.Visual examination of the returned devices identified that the drill pin was seized in one of the guide holes, was bent and exhibited signs of repeated use (nicked/gouged/striations/hex feature stripped).Dimensional analysis of the product determined that the product was conforming to print specifications where measured.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
 
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Brand Name
PERSONA PARTIAL KNEE TIBIAL CUT GUIDE 5 DEGREES
Type of Device
INSTRUMENT, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14516823
MDR Text Key292964572
Report Number0001822565-2022-01551
Device Sequence Number1
Product Code HSX
UDI-Device Identifier00889024582842
UDI-Public(01)00889024582842(10)64687543
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 08/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42539905195
Device Lot Number64687543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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