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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 10 MM THICKNESS; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 10 MM THICKNESS; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 ¿ 2020 - 00964, 0001822565 ¿ 2020 - 00965, 0001822565 ¿ 2020 - 00966, 0001822565 ¿ 2020 - 00967, 0001822565 ¿ 2020 - 00968, 0001822565 ¿ 2020 - 00969, 0001822565 ¿ 2020 - 00970, 0001822565 ¿ 2020 - 00971, 0001822565 ¿ 2020 - 00972, 0001822565 ¿ 2020 - 00973, 0001822565 ¿ 2020 - 00974, 0001822565 ¿ 2020 - 00975, 0001822565 ¿ 2020 - 00976, 0001822565 ¿ 2020 - 00977, 0001822565 ¿ 2020 - 00978, 0001822565 ¿ 2020 - 00979, 0001822565 ¿ 2020 - 00980, 0001822565 ¿ 2020 - 00981, 0001822565 ¿ 2020 - 00982, 0001822565 ¿ 2020 - 00983.
 
Event Description
It was reported that the device was missing one or more ball bearings that appear to be detaching during or after the sterilization process.There was no patient involvement.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed as no products or images were provided for a visual inspection to be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A root cause was unable to be determined.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 Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The returned tasp lot 62702757 exhibits signs of repeated use (nicked or gouged) and has one of components 1 and 2 disassembled / missing.The missing component was not returned.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 10 MM THICKNESS
Type of Device
PROSTHESIS, KNEE
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 Key9847828
MDR Text Key183920390
Report Number0001822565-2020-00964
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42527900200
Device Lot Number62702757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2014
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
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