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

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.

• 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 Key: 17788356
• MDR Text Key: 323920191
• Report Number: 0001822565-2023-02614
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• 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 Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other