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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CENTRAL SCREW; SHOULDER PROSTHESIS/EXTREMITIES
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ZIMMER BIOMET, INC. UNKNOWN CENTRAL SCREW; SHOULDER PROSTHESIS/EXTREMITIES Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00241, 0001825034-2022-00243, 0001825034-2022-00244, 0001825034-2022-00245, 0001825034-2022-00246.Medical products: item#: 110027734, compr vrs glen pps min tpr adr; lot#: 298290.Item#: unknown, unknown locking screw; lot#: unknown.Item#: unknown, unknown locking screw; lot#: unknown.Item#: unknown, unknown locking screw; lot#: unknown.Item#: unknown, unknown locking screw; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent a first stage revision of a right shoulder prosthesis approximately four weeks post implantation due to insufficient fixation of the glenoid components.The patient was implanted with a hemiarthroplasty and cement spacers until a custom glenoid component is available.No additional information is available at this time.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00241, 0001825034-2022-00243, 0001825034-2022-00244, 0001825034-2022-00245, 0001825034-2022-00246.Concomitant medical products: item#: 110027734, compr vrs glen pps min tpr adr; lot#: 298290.Item#: unknown, unknown locking screw; lot#: unknown.Item#: unknown, unknown locking screw; lot#: unknown.Item#: unknown, unknown locking screw; lot#: unknown.Item#: unknown, unknown locking screw; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent a first stage revision of a right shoulder prosthesis approximately four weeks post implantation due to insufficient fixation of the glenoid components.The patient was implanted with a hemiarthroplasty and cement spacers until a custom glenoid component is available.No additional information is available at this time.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00241-1, 0001825034-2022-00243-1, 0001825034-2022-00244-1, 0001825034-2022-00245-1, 0001825034-2022-00246-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot 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
UNKNOWN CENTRAL SCREW
Type of Device
SHOULDER PROSTHESIS/EXTREMITIES
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 Key13453295
MDR Text Key285152792
Report Number0001825034-2022-00242
Device Sequence Number1
Product Code HSD
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 03/18/2022
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 NumberUNKNOWN
Device Lot 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 01/11/2022
Initial Date FDA Received02/04/2022
Supplement Dates Manufacturer Received03/07/2022
Supplement Dates FDA Received03/23/2022
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
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
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