MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X30 ST; 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
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110030778, cr 40mm glenosphere +6mm cocr, lot # 11024182.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 #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 947820.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: 0001822565-2023-01467, 0001822565-2023-01468, 0001825034-2023-01229, 0001825034-2023-01230, 0001825034-2023-01231, 0001825034-2023-01232, 0001825034-2023-01234.Requested but not returned by hospital.
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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed as mmi reported no signs of loosening.Visual examination of the provided pictures identified the explanted baseplate, taper, 4 screws (2 locking, central, and non-locking),glenosphere, and liner.The glenosphere and taper are attached and biodebris is present on all implants.However, as the products were not returned, further analysis could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left reversetype arthroplasty is present.On both images, there is asymmetric alignment of the glenosphere with the glenoid baseplate consistent with implant disassociation.There is no fracture or evidence of implant loosening.Implant fit appears maintained.Bone quality appears mildly osteopenic.There is no radiographic evidence of trauma.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X30 ST
• Common Device Name: EXTREMITIES IMPLANTS
• 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: 17038654
• Report Number: 0001825034-2023-01233
• Device Sequence Number: 20557249
• Product Code: KWS
• UDI-Device Identifier: 00880304677272
• UDI-Public: (01)00880304677272(17)320316(10)847860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080642
• 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): 11/22/2023

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: 180560
• Device Lot Number: 847860
• 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: 11/14/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male