MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE +6MM COCR; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had initial surgery approximately 6 months ago.Subsequently, there was a revision due to loosening about 20 days ago.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 00434904000, 40mm ã¿ +0mm offset poly liner, lot # 65172970.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 559160.Catalog #: 110032430, comp aug mini bsplt w tpr lg, lot # 65019302.Catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 988830.Catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 155960.Catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 847860.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 947820.G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was 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: 0001822565-2023-01468, 0001825034-2023-01229, 0001825034-2023-01230, 0001825034-2023-01231, 0001825034-2023-01232, 0001825034-2023-01233, 0001825034-2023-01234.Requested but not returned by hospital.
Additional Manufacturer Narrative
(b)(4).Proposed code: mechanical (g04)- head.Reported event was unable to be confirmed as the x-rays found no fracture, abnormal radiolucency, or evidence of implant loosening.The implant fit appears maintained and bone quality appears mildly osteopenic.There is no radiographic evidence of trauma.On both images, there is asymmetric alignment of the glenosphere with the glenoid base plate consistent with implant disassociation.However, this is only suspected glenosphere not confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.No problem was found with the device.Loosening occurs for implanted products interacting directly with the bone.The glenosphere does not interact with the bone.Suspected implant disassociation occurs between baseplate and taper adapter sold with the baseplate.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: CR 40MM GLENOSPHERE +6MM COCR
• Common Device Name: EXTREMITIES IMPLANTS
• 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: 17037729
• Report Number: 0001822565-2023-01467
• Device Sequence Number: 6460175
• Product Code: KWS
• UDI-Device Identifier: 00887868231278
• UDI-Public: (01)00887868231278(17)290331(10)11024182
• 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: 2022
• 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): 09/15/2023

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: 110030778
• Device Lot Number: 11024182
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male