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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD TOP INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD TOP INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has not indicated whether the product will be returned or not, to zimmer biomet for investigation. Additional requests have been sent to the customer. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the cps poly broke. Attempts have been made and no further information has been provided at this time.
 
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Brand NameCPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD TOP
Type of DeviceINSTRUMENT, 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 Key11728177
MDR Text Key248157598
Report Number0001822565-2021-01165
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527600510
Device Lot Number62695297
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2014
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

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