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

Catalog Number	XL-115363
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Procode: phx.Medical products: comprehensive reverse 25mm baseplate + adaptor cat# 010000589 lot# 435290, comprehensive primary stem 11mm mini cat# 113631 lot# 950540, comprehensive reverse shoulder glenosphere std 36mm cat# 115310 lot# 654310 , comprehensive reverse tray co 44mm cat# 115370 lot# 382000, comprehensive reverse central screw 6.5x35mm st/rst cat# 115397 lot# 193820, comprehensive locking screw3.5hex 4.75x25 st cat# 180552 lot# 224610, comprehensive locking screw 3.5hex 4.75x25 st cat# 180552 lot# 224610, comprehensive nonlocking screw 3.5hex 4.75x20 st cat# 180558 lot# 372940.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01832, 0001825034 - 2022 - 01833, 0001825034 - 2022 - 01835, 0001825034 - 2022 - 01837, 0001825034 - 2022 - 01839, 0001825034 - 2022 - 01840, 0001825034 - 2022 - 01841, 0001825034 - 2022 - 01842.
Event or Problem Description
It was reported patient is experiencing shoulder pain, instability, and rom issues approximately seven years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 15212197
• Report Number: 0001825034-2022-01834
• Device Sequence Number: 2067674
• Product Code: PHX
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)200611(10)249640
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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 Expiration Date: 06/11/2020
• Device Catalogue Number: XL-115363
• Device Lot Number: 249640
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White