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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667); Failure to Osseointegrate (1863); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 03/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products:: 00434903611 64463135 glenosphere 36 mm diameter.0104211123 3015699 anatomical shoulderâ¿¢, humeral stem, cemented, 㸠12, 100 mm.0104223100 3032165 anatomical shoulderâ¿¢ reverse, humeral cup, 0â°, retro.Unk stem extremities impl.Foreign country: (b)(6).Reported event was confirmed by review of radiographs received.Review of the available records identified there is abnormal slightly increased spacing inferiorly between the base plate in the glenosphere when compared to the spacing more superiorly.This could be related to several possibilities, including but not limited to instability of the base plate (fracture as reported), improper integration of the hardware components, or improperly positioned components upon implantation.No radiographic signs of loosening.Remainder of the hardware appears intact and well integrated without periprosthetic lucencies.Bones are intact without fracture.Visual examination of the returned products identified the tm reverse shoulder base plate had damage on the taper, and the zimmer tm reverse shoulder glenosphere showed damage/scratches on the outer surface.The conical taper exhibited no damage.The device history record (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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02885.
 
Event Description
It was reported patient underwent initial shoulder arthroplasty.Subsequently the patient was revised due to possible instability, disassociation, implant fracture and improper integration.During the removal, it was reported the glenoid had loosened or was improperly positioned.When the surgeon inserted the humeral plate, he had to use a lot of tension and strength.As a result, it may have happened that he used the levers to push the glenosphere back off.The base plate has also broken out.There was no mention of a traumatic event.In addition, the humeral shell could not be separated from the shaft.Cement got into the gap between the shaft and the cone.The cemented stem was explanted with the shell.Abnormal spacing is seen on x-rays received.Attempts have been made and additional information on the reported event is unavailable.
 
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Brand Name
BASE PLATE 15 MM POST LENGTH UNCEMENTED
Type of Device
PROSTHESIS, SHOULDER
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 Key12598881
MDR Text Key275472764
Report Number0001822565-2021-02884
Device Sequence Number1
Product Code KWS
UDI-Device Identifier00889024268999
UDI-Public(01)00889024268999(17)291231(10)64612803
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130661
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/05/2021
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00434901500
Device Lot Number64612803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received10/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2020
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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