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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL GLENOSPHERE 36MM; PROSTHESIS, SHOULDER
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ZIMMER, INC. ZIMMER TRABECULAR METAL GLENOSPHERE 36MM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: catalog no: 00434901500, lot no: 63480530, description: trabecular metal base plate 15 mm post length.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated report: 1822565-2017-02132.
 
Event Description
It was reported that patient underwent reverse total shoulder arthroplasty, and that the glenosphere was not fully seated on the baseplate during the procedure.No patient consequences were reported as a result of the malfunction at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to report additional information.Upon reassessment of the reported event, it was determined to be not reportable, as the malfunction was corrected during surgery and would not lead to harm or injury to the patient.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-ray reviewer stated "reverse shoulder system arthroplasty is in place.Lateral skin staples are present consistent with recent postop status.The glenosphere is not fully seated, and is angled asymmetrically on the base plate." device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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 patient underwent reverse total shoulder arthroplasty, and that the glenosphere was not fully seated on the baseplate during the procedure.No patient consequences were reported as a result of the malfunction at this time.The surgeon claims to have corrected the issue during the procedure and does not plan to revise the patient.
 
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Brand Name
ZIMMER TRABECULAR METAL GLENOSPHERE 36MM
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6465529
MDR Text Key72188362
Report Number0001822565-2017-02133
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK121543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number00434903611
Device Lot Number63399742
Other Device ID NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2016
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) Other;
Patient Age85 YR
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