MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +6 OFFSET; SHOULDER, PROSTHESIS

Catalog Number	110031405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to infection approximately seven weeks post initial procedure.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: 0001822565-2023-03637, 0001822565-2023-03639, 0001822565-2023-03640.D10: unk poly +6, unk glenosphere, unk screws, unk stem, unk baseplate.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.H3 other text : product not returned.
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.Mulltiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03639, 0001822565-2023-03640, 0001822565-2023-03637, 0001825034-2024-00757, 0001825034-2024-00756, 0001825034-2024-00755, 0001825034-2024-00752, 0001825034-2024-00750.D10: cr vivacit-e 36mm brng +3 cat: 110031425 lot: 65809012.Mini tray std cocr +6 offset cat: 110031405 lot: 66100902.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7531733.Comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 66177946.Comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 66098120.Comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 66008607.Comp rvs cntrl 6.5x40mm st/rst cat: 115398 lot: 65962140.Comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 66021321.25mm versa-dial taper adaptor cat: 118000 lot: j7217167.As product id was received and sterile certs were reviewed, this event will be considered not reportable.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: MINI TRAY STD COCR +6 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: 18327672
• Report Number: 0001822565-2023-03638
• Device Sequence Number: 15160278
• Product Code: KWS
• UDI-Device Identifier: 00887868231377
• UDI-Public: (01)00887868231377(17)330625(10)66100902
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 03/20/2024
• 2 Devices were Involved in the Event: 1 2

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: 110031405
• Device Lot Number: 66100902
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 100 KG