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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PHOENIX 5MM SCREW AND ENDCAP; TRAUMA IMPLANT

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ZIMMER BIOMET, INC. PHOENIX 5MM SCREW AND ENDCAP; TRAUMA IMPLANT Back to Search Results
Catalog Number 14-440068
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 04/16/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: foreign - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient was revised approximately 10 months post initial procedure due to heel pain.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
 
Event Description
No additional event information is available at the time of this report.
 
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Brand Name
PHOENIX 5MM SCREW AND ENDCAP
Type of Device
TRAUMA IMPLANT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11712272
MDR Text Key247465417
Report Number0001825034-2021-01214
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-440068
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2021
Initial Date FDA Received04/22/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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