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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: unknown, unknown glenosphere, lot # unknown; catalog #: 115370, comp rvs tray co 44mm, lot # 919120; catalog #: xl-115365, arcom xl 44-36 rtnv+3 hmrl brg, lot # 875730; catalog #: 115340, comp rvs hmrl ti tray 44mm, lot # unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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: 0001825034-2021-02800.Product was discarded.
Event or Problem Description
It was reported that a patient underwent a reverse shoulder replacement for a delayed proximal humeral fracture using the comprehensive system.At the time the operation went as planned.Patient came back to clinic recently and had described that she heard a click in her shoulder lifting a heavy box but no pain or change to range of movement.Patient then reported that she was out walking the dog and the dog pulled on the leash.Since then she has experienced more pain and discomfort at shoulder.On review at clinic recently the x-ray showed that the shoulder was out of joint and would require revision surgery.The patient was revised of the humeral tray and humeral bearing of the comprehensive reverse (all other implants were left as planned) approximately a week ago.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12590083
• Report Number: 0001825034-2021-02799
• Device Sequence Number: 11702996
• Product Code: KWS
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)250721(10)792100
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 07/21/2025
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 792100
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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
• 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
• Patient Sex: Unknown