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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HERBERT PM COMPR RVS HA BP; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. HERBERT PM COMPR RVS HA BP; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 04/24/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).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.Unique identifier (udi) #: n/a.Concomitant medical products: 118001, versa-dial/comp ti std taper, lot 194470; 113648, comp primary stem 8mm std, lot 864660; 115323, comp rvsr shldr glnsp +3 41mm, lot 788010; 115370, comp rvs tray co 44mm, lot 448500; ep-115397, e1 44-41 std +3 hmrl brg, lot 230960; 115386, comp rvs cntrl scr 6.5x50mm st, lot 269000; 180554, comp lk scr 3.5hex 4.75x35 st, lot 729380; 180554, comp lk scr 3.5hex 4.75x35 st, lot 932440; 180552, comp lk scr 3.5hex 4.75x25 st, lot 376810; 180556, comp lk scr 3.5hex 4.75x45 st, lot 620150.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01171; 0001825034 - 2019 - 01172; 0001825034 - 2019 - 01173; 0001825034 - 2019 - 01174; 0001825034 - 2019 - 01176.
 
Event Description
It was reported that approximately 5 years post implantation, the patient has been indicated for a shoulder revision due to unknown reasons.Attempts have been made and no further information has been provided.
 
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.Dhr was reviewed and no discrepancies relevant to the reported event 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
No further event information available at the time of this report.
 
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Brand Name
HERBERT PM COMPR RVS HA BP
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8421542
MDR Text Key138822695
Report Number0001825034-2019-01170
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
CUSTOM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/14/2024
Device Model NumberN/A
Device Catalogue NumberPM555222
Device Lot Number728920
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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