MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; SHOULDER, PROSTHESIS

Catalog Number	113952
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: anatomical shoulder domelock, dome, centric cat: 0104227005 lot: 2975075.Anatomical shoulder domelock, humeral head cat: 0104212465 lot: 2902802.Anatomical shoulder humeral stem, uncemented cat: 0104201123 lot: 2979183.G2: foreign: belgium.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Records from the study were provided and reviewed by a health care professional.Review of the available records identified the following: rotator cuff tear with rupture/disinsertion of the cranial fibers of the subscapularis and extensive interstitial cleavage tear of the supraspinatus noted.Patient underwent open rotator cuff repair.Visits noted no pain and no significant findings on xrays.The patient underwent revision to right reverse shoulder arthroplasty due to instability.The reported event is not confirmed.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.H3 other text : product not returned.
Event or Problem Description
It was reported underwent a revision procedure to a reverse total shoulder for instability and two events of luxation approximately two years post initial procedure.All components, except for stem, was revised.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: SM HYBRID GLENOID BASE 4MM
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 18866428
• Report Number: 0001825034-2024-00523
• Device Sequence Number: 8135908
• Product Code: MBF
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)250219(10)692830
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 03/08/2024

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: 02/19/2025
• Device Catalogue Number: 113952
• Device Lot Number: 692830
• 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: 08/24/2023
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 54 KG