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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CONVERTIBLE GLENOID BASEPLATE; SHOULDER, PROTHESIS

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ZIMMER BIOMET, INC. UNKNOWN CONVERTIBLE GLENOID BASEPLATE; SHOULDER, PROTHESIS Back to Search Results
Catalog Number UNKNOWN
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 07/26/2023
Event Type  Injury  
Event Description
It was reported that the patient was revised due to bearing disassociation approximately six months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 -02267, 0001825034-2023-02012.D10: comp conv glen liner vivacit-e; cat: 110035767; lot: 65163943; mini tray std cocr +0 offset; cat: 110031399; lot: 65949545; versa-dial/comp ti std taper; cat: 118001; lot: 808600; comp rvrs shldr glnsp std 36mm; cat: 115310; lot: j7505348; hmrl bearing 36 mm std vite; cat: 110031424; lot: 65761078; versa-dial 46x18x53 hum head; cat: 113042; lot: j7298805; versa-dial/comp ti std taper; cat: 118001; lot: j7379786.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided for the unknown baseplate; visual and dimensional evaluations could not be performed.Medical records for the initial surgery were provided and reviewed by a health care professional.Review of the available records identified the following: rotator cuff intact.Glenoid convertible baseplate.Anatomic total shoulder performed without complications.Intraop imaging show good alignment of components.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The reported event is not confirmed; the revision is confirmed as pictures were provided and product returned, however the occurrence of disassociation cannot be confirmed.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.
 
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Brand Name
UNKNOWN CONVERTIBLE GLENOID BASEPLATE
Type of Device
SHOULDER, PROTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18245463
MDR Text Key329440459
Report Number0001825034-2023-02819
Device Sequence Number1
Product Code HXX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2023
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 Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/03/2023
Initial Date FDA Received12/01/2023
Supplement Dates Manufacturer Received11/30/2023
Supplement Dates FDA Received12/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
Patient Weight56 KG
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