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

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is getting pathology tested.The investigation is in process.Once the investigation has been completed, a follow-up mir will be submitted.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.Device product code : phx.Concomitant products: part# 115370, lot 944340; part# pt-113950; lot# 682270; part# 113648; lot# 647510; part# 118001; lot# 384530; part# 115310; lot# 042090; part# 180560; lot# 114970; part# 180558; lot# 330140; part# 180553; lot# 687720; part# 180553; lot# 093880; part# 115398; lot# 714870; part# 115330; lot# 157840; report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00424, 0001825034 - 2022 - 00426, 0001825034 - 2022 - 00427, 0001825034 - 2022 - 00428, 0001825034 - 2022 - 00429, 0001825034 - 2022 - 00430, 0001825034 - 2022 - 00431, 0001825034 - 2022 - 00432, 0001825034 - 2022 - 00433, 0001825034 - 2022 - 00434, 0001825034 - 2022 - 00435.
Event or Problem Description
It was reported that the patient underwent a reverse shoulder arthroplasty on an unknown date.Subsequently, in an unknown timeframe post-implantation, the patient was revised due to aseptic loosening with periprosthetic osteolysis, wear of the poly component, and metallosis.Attempts have been made and no further information has been provided.
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 investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a4; b4; b5; g3; g6; h1; h2; h3; h6 visual examination of the provided photographs identified that the bearing is worn.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: large lucency noted in the glenoid, likely indicating multiple possibilities, including metallosis.Additionally, there are secondary findings that could be related to polyethylene wear including possible metal on metal contact between the glenosphere and the humeral tray.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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 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: 13633482
• Report Number: 0001825034-2022-00425
• Device Sequence Number: 5039202
• Product Code: PHX
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)220619(10)798550
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

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: 06/19/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 798550
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 06/09/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/11/2022; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 48 KG