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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE HUMERAL TRAY; EXTREMITY IMPLANT

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ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE HUMERAL TRAY; EXTREMITY IMPLANT Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Rheumatoid Arthritis (1724); Joint Dislocation (2374); Subluxation (4525)
Event Type  Injury  
Event Description
It was reported that a patient has a reverse shoulder in situ that has failed due to patient rheumatoid condition.Further information provided indicates that the patient's humeral tray and glenoid are loose within the joint.No revision procedure has been reported to date.Attempts have been made and there is no further information at this time.
 
Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: unknown, glenoid, lot # unknown.G2: uk.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02613.
 
Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: unknown, bearing, lot # unknown.Catalog #: unknown, head, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03415.
 
Event Description
No further event information available at the time of this report.
 
Event Description
It was reported that a patient has a reverse shoulder in situ that has failed due to patient rheumatoid condition.Further information provided indicates that the patient's humeral tray and glenoid are loose within the joint.Additionally, the pmi request states the patient has had significant erosive changes in the bone as well as history of subluxation/dislocation and the tray disassociated from the stem.No revision procedure has been reported to date.Attempts have been made and there is no further information at this time.
 
Manufacturer Narrative
(b)(4).D10: medical product: catalog #: unknown, glenoid, lot # unknown.Catalog #: unknown, stem, lot # unknown.Catalog #: unknown, baseplate, lot # unknown.Catalog #: unknown, screw, lot # unknown x 5.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02613, 0001822565-2023-03088, 0001822565-2023-03089, 0001822565-2023-03090, 0001822565-2023-03091, 0001822565-2023-03092, 0001822565-2023-03093, and 0001822565-2023-03094.
 
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 other new information.Investigation and root cause remains unchanged.
 
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Brand Name
UNKNOWN COMPREHENSIVE HUMERAL TRAY
Type of Device
EXTREMITY IMPLANT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key17788356
MDR Text Key323920191
Report Number0001822565-2023-02614
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 02/19/2024
2 Devices were Involved in the Event: 1   2  
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 NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/25/2023
Initial Date FDA Received09/21/2023
Supplement Dates Manufacturer Received10/16/2023
11/21/2023
02/15/2024
Supplement Dates FDA Received11/10/2023
12/07/2023
02/19/2024
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
Patient Outcome(s) Other;
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