MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VRS GLENOID VRS BONE AND IMPLANT MODEL; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110027734, compr vrs glen pps min tpr adr, lot # 66402490.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2024-00010.
Event or Problem Description
It was reported that the bone model and the implant did not match patient anatomy at all at the time of surgery.The surgeon felt it was in the best interest to not remove bone that is necessary for the pmi to be placed.A scan was provided that verifies the bone to be excised is intact, causing the implant to not fit correctly.The technique for this was provided indicating removal of said bone with model of patient's anatomy.Attempts have been made and there is no further information at this time.
Event or Problem Description
It was further reported that to complete the procedure, the surgeon implanted a spacer until another product matched implant could be made.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event of the vrs not fitting the patient cannot be confirmed.However, it was confirmed with pmi scans that the necessary reaming was not performed.Visual examination of the returned product identified the product was returned in its original packaging but opened.Parts are 100% inspected at the time of manufacture with a blue lights scan and a functional fit test is performed with the bone and implant model.Medical records were not provided.A review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to use error as the necessary bone reaming for fit per procedure was not performed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).D6a - 2007.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
It was further reported that the patient had initial surgery about 17 years ago.The surgeon felt it was in the best interest to not remove bone that is necessary for the pmi implant to be placed.Scan was provided that verifies the bone to be excised is intact, causing the implant to not fit correctly.The technique for this was provided indicating removal of said bone with model of patient's anatomy.

• Brand Name: COMPREHENSIVE VRS GLENOID VRS BONE AND IMPLANT MODEL
• 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: 18464390
• Report Number: 0001825034-2024-00011
• Device Sequence Number: 19604788
• Product Code: PHX
• UDI-Device Identifier: 00880304818958
• UDI-Public: (01)00880304818958(17)240503(10)66402581
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: N/A
• Device Catalogue Number: 110019066
• Device Lot Number: 66402581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/15/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 03/21/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/02/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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: Other
• Patient Sex: Unknown