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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER Back to Search Results
Catalog Number 180554
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Anemia (1706)
Event Date 04/30/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Product code: phx.Udi: (b)(4).Concomitant medical products: 113631 723680 comp primary stem 11mm mini; 115370 059230 comp rvs tray co 44mm; xl-115366 856240 acrom xl 44-41 std hmrl brng; 115323 693530 comp rvsr shldr glnsp +3 41mm; 010000589 234640 comp rvrs 25mm bsplt ha+adptr; 115396 947670 comp rvs cntrl 6.5x30mm st/rst; 180552 575560 comp lk scr 3.5hex 4.75x25 st; 180552 715580 comp lk scr 3.5hex 4.75x25 st; 180550 748350 comp lk scr 3.5hex 4.75x15 s.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.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: 0001825034-2019-03559, 0001825034-2019-03560, 0001825034-2019-03561, 0001825034-2019-03562, 0001825034-2019-03563, 0001825034-2019-03564, 0001825034-2019-03565, 0001825034-2019-03566, 0001825034-2019-03567.
 
Event Description
It was reported the patient underwent a primary right reverse shoulder arthroplasty.Subsequently, three days post op the patient experienced chest pain secondary to possible pulmonary embolism.Patient treated for pulmonary embolism and anemia.No additional patient consequences are known at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.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 LK SCR 3.5HEX 4.75X35 ST
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8890047
MDR Text Key154312302
Report Number0001825034-2019-03568
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
PMA/PMN Number
K132239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number180554
Device Lot Number565860
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age63 YR
Patient Weight117
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