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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 13MM MINI; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. COMP PRIMARY STEM 13MM MINI; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 03/02/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 115370, comp rvs tray co 44mm, 782800; xl-115366, acrom xl 44-41 std hmrl brng, 624930; 115320, comp rvrs shldr glnsp std 41mm, 976810; 010000589, comp rvrs 25mm bsplt ha+adptr, 563630; 115396, comp rvs cntrl 6.5x30mm st/rst, 323180; 180553, comp lk scr 3.5hex 4.75x30 st, 653100; 180551, comp lk scr 3.5hex 4.75x20 st, 369350; 180550, comp lk scr 3.5hex 4.75x15 st, 502960; 180554, comp lk scr 3.5hex 4.75x35 st, 429640.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03475, 0001825034-2019-03476, 0001825034-2019-03477, 0001825034-2019-03478, 0001825034-2019-03479, 0001825034-2019-03480, 0001825034-2019-03482, 0001825034-2019-03483, 0001825034-2019-03484 customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.Reported event was confirmed by review of operative notes.Operative notes state the presence of hematoma and required medical intervention of open irrigation and debridement.Dhr was reviewed and no discrepancies were found.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
It was reported that hematoma was developed on patient's right shoulder one month post implantation and required medical intervention of open irrigation and debridement.No products explanted and no further complications reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The root cause for the infected hematoma was due to the fall experienced by the patient with traumatic removal of the hemovac.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.
 
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Brand Name
COMP PRIMARY STEM 13MM MINI
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8878596
MDR Text Key153816303
Report Number0001825034-2019-03473
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
PMA/PMN Number
K060692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number113633
Device Lot Number730900
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight80
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