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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY PROSTHESIS, EXTREMITIES

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ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY PROSTHESIS, EXTREMITIES Back to Search Results
Model Number N/A
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Pain (1994)
Event Date 03/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product(s): unknown ulna; unknown articulation kit. Report source: foreign: event occurred in (b)(6). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00892. Device evaluated by mfr: product not returned.
 
Event Description
It was reported patient underwent a revision procedure approximately 14 months post-implantation due to loosening and pain.   attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameHUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY
Type of DevicePROSTHESIS, EXTREMITIES
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 Key9843510
MDR Text Key191862717
Report Number0001822565-2020-00891
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840004510
Device Lot Number63710101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/17/2020 Patient Sequence Number: 1
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