MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VRS GLENOID PATIENT MATCHED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110027734
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has not indicated whether the product will be zimmer biomet for investigation, and it may remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 reported that during a surgery, the surgeon questioned why the central screw was not reading the amount that was recorded on the screw schematic.It was observed that the implant most likely was not seated correctly.After a review of the 3d-modeled surgical plan, it was discovered that the implant had been implanted upside down.No patient consequences or plans for revision have been communicated at this time.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: associated product information, part number (lot number): ¿ 110031378 (66518780).¿ 110019066 (66518781).¿ 110019066-01 (66518782).¿ 110019066-02 (66518783).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.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.The following sections were corrected: a2; b6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the right shoulder demonstrates a reverse total shoulder arthroplasty with inferior positioning of the glenoid component with respect to the scapula.Central screw appears to be protruding through the scapula.No dislocation.Osteopenia is present.Findings suggestive of malposition of the glenoid component of a right reverse total shoulder arthroplasty.The root cause of the reported issue is attributed to user error as the glenoid was implanted upside down.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: COMPREHENSIVE VRS GLENOID PATIENT MATCHED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18872230
• Report Number: 0001825034-2024-00643
• Device Sequence Number: 12692997
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)240719(10)66518779
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2024
• Device Catalogue Number: 110027734
• Device Lot Number: 66518779
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 07/25/2024
• Initial Report FDA Received Date: 03/10/2024
• Supplement Report FDA Received Date: 04/02/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male