MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +0 OFFSET; SHOULDER, PROSTHESIS

Catalog Number	110031399
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to bearing disassociation approximately six months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02012.D10: comp conv glen liner vivacit-e cat: 110035767, lot: 65163943.Versa-dial/comp ti std taper cat: 118001 lot: 808600.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7505348.Hmrl bearing 36 mm std vite cat: 110031424 lot: 65761078.Versa-dial 46x18x53 hum head cat: 113042 lot: j7298805.Versa-dial/comp ti std taper cat: 118001 lot: j7379786.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h6, h10 corrected: h4 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.As the product meets the applicable acceptance criteria, a limited investigation will be performed.A review of manufacturing records is not required.No problem found; this humeral tray is unrelated to the reported event of disassociation.There are no allegations against the humeral tray as it was implanted during the revision procedure.The reported event is not confirmed.This event will be considered not reportable as the tray is not related to the event.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 available at the time of this report.

• Brand Name: MINI TRAY STD COCR +0 OFFSET
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 17611206
• Report Number: 0001822565-2023-02267
• Device Sequence Number: 12617735
• Product Code: KWS
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)330421(10)65949545
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/13/2023

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 Catalogue Number: 110031399
• Device Lot Number: 65949545
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 11/09/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/03/2023; 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 56 KG