MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3 PEG MONO GLEN SZ 2; PROSTHESIS, SHOULDER

Catalog Number	SAGL2022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Subluxation (4525)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following section was corrected: h4.Reported event was confirmed by review of medical records.Review of the available records identified the following: on (b)(6) 2024 pt reported that they "slept wrong".Initial appt noted pain, reduced rom, posterior subluxation, and negative labs.A displaced coracoid tip fracture was also noted.Implants aligned and well fixed.Manipulation (closed reduction) was attempted with no success, sent to referral/revising surgeon.On (b)(6) 2024 consult with revising surgeon noted no history of trauma, limited rom, axillary nerve slight paresthesia, drop arm positive, with joint dislocation.On (b)(6) 2024, pt revised to reverse tsa.Revision notes posterior dislocation, muscular tissues dense and scarred.Humeral head centricity rotated posterior inferior, stem appeared to be degrees of retroversion.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following section was corrected: e1.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 reported that the patient's left glenoid was revised two months post-initial procedure due to pain, limited rom, bone fracture, and subluxation.No additional patient consequences were reported.

• Brand Name: 3 PEG MONO GLEN SZ 2
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18827529
• Report Number: 0001822565-2024-00694
• Device Sequence Number: 3008681
• Product Code: KWS
• UDI-Device Identifier: 00889024644670
• UDI-Public: (01)00889024644670(17)280627(10)66074643
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 07/03/2024

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 Catalogue Number: SAGL2022
• Device Lot Number: 66074643
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 06/24/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/18/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 65 KG