MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE STD COCR; EXTREMITIES IMPLANT

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a shoulder procedure on approximately 3 months ago.Subsequently, the patient was revised due to dislocation 2 months later.The patient's soft tissues are severely compromised, and the patient did not keep his shoulder immobilized as instructed.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).G2: australia.D10 - medical product: catalog #: 110031427, bearing standard 40 mm diameter, lot # 65494017.Catalog #: 110031399, mini tray std cocr +0 offset, lot # 65604025.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00954 h3 other text : requested but not returned by hospital.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d2, g3, h1, h2, h3, h6, h10 proposed g-code: mechanical (g04) - head reported event was confirmed as as dislocation was noted in the x-ray review.Review of the x-rays identified the following: no hardware disassociation, but there is dislocation of the humeral component with respect to the glenosphere in which the humerus is dislocated proximally and slightly laterally.No loosening, wear, radiolucency, or other contributing factors.Overall fit is grossly unremarkable.Bone quality appears normal.No fracture of the bones or hardware, and no anatomical concerns detected to account for the finding.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error, patient not following instructions.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.

• Brand Name: CR 40MM GLENOSPHERE STD COCR
• Common Device Name: EXTREMITIES IMPLANT
• 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 Key: 16876489
• Report Number: 0001825034-2023-00955
• Device Sequence Number: 15318723
• Product Code: KWS
• UDI-Device Identifier: 00887868231254
• UDI-Public: (01)00887868231254(17)320928(10)65487259
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110030776
• Device Lot Number: 65487259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male