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

Catalog Number 113952

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Subluxation (4525)

Event Date 11/25/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 337225852
• Report Number: 0001825034-2024-00523
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)250219(10)692830
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 54 KG