MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product code: phx.Concomitant products: 115310 comp rvrs shldr glnsp std 36mm 870560; 010000589 comp rvrs 25mm bsplt ha+adptr 241790; 12-113556 compr 6mm hum fract stem pps 456480; 115375 comp rvs tray +5mm co 44mm 018900.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01418, 0001825034 - 2021 - 01420 , 0001825034 - 2021 - 01422 , 0001825034 - 2021 - 01424.
Event or Problem Description
It was reported that patient underwent left comprehensive reverse shoulder procedure.The patient underwent a revision procedure three years later due to pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of medical records.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 report 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: ARCOM XL 44-36 STD +3 HMRL BRG
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11800933
• Report Number: 0001825034-2021-01423
• Device Sequence Number: 3535082
• Product Code: PHX
• UDI-Device Identifier: 00880304475434
• UDI-Public: (01)00880304475434(17)230228(10)096260
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 096260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention