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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; INSTRUMENT KNEE

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ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; INSTRUMENT KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the device was discovered to have missing components.Attempts to obtain additional information have been made; however, no more is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified signs of use.The returned shim was missing a ball bearing.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.This device is confirmed to have been a part of a capa investigation.Field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.Complaint is confirmed based on the product evaluation.If any further information is received 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
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM
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 Key17644331
MDR Text Key322205598
Report Number0001822565-2023-02316
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42527900704
Device Lot Number62215877
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/09/2023
Initial Date FDA Received08/29/2023
Supplement Dates Manufacturer Received12/15/2023
Supplement Dates FDA Received12/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZFA 2014-67; Z-1052-2015
Patient Sequence Number1
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