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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE MINI HUMERAL STEM; PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. COMPREHENSIVE MINI HUMERAL STEM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 02/28/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 115310 comp rvrs shldr glnsp std 36mm 129260; 010000589  comp rvrs 25mm bsplt ha+adptr 592930 ; 115370 comp rvs tray co 44mm 596600 ; ep-115393 e1 44-36 std hmrl brng 734030 ; 180558 comp nlk scr 3.5hex 4.75x20 st 860890 ; 180560 comp nlk scr 3.5hex 4.75x30 st 018440 ; 115397 comp rvs cntrl 6.5x35mm st/rst 569900.The investigation is in progress.Once the investigation is completed a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 06009; 0001825034 - 2018 - 06014; 0001825034 - 2018 - 06029; 0001825034 - 2018 - 06031.
 
Event Description
It was reported that the patient underwent a reverse total shoulder arthroplasty, and was revised due to unknown reasons approximately five (5) months post-implantation.No additional information is available at this time.
 
Manufacturer Narrative
Upon reassessment of the reported based on additional information.It was determined that the product did not contribute to the reported event.The initial report submitted should be voided.
 
Event Description
Upon reassessment of the reported based on additional information.It was determined that the product did not contribute to the reported event.The initial report submitted should be voided.
 
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Brand Name
COMPREHENSIVE MINI HUMERAL STEM
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7754445
MDR Text Key116211042
Report Number0001825034-2018-06025
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
PMA/PMN Number
PK060692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 01/10/2019
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number113629
Device Lot Number979660
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2018
Initial Date FDA Received08/06/2018
Supplement Dates Manufacturer Received01/09/2019
Supplement Dates FDA Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
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