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	Unstable (1667)
Health Effect - Clinical Codes	Erosion (1750); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product code: phx.Concomitant medical products: ref 113626 lot 646940 humeral stem.Ref 115370 lot 632000 humeral tray.Ref 115310 lot 708330 glenosphere.Ref 110032410 lot 64265378 glenoid baseplate.Ref 115396 lot 851690 central screw.Ref 180551 lot 795380 screw.Ref 180552 lot 252690 screw.Ref 180550 lot 204230 screw.Ref 180550 lot 796740 screw.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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 - 02198.0001825034 - 2021 - 02200.
Event or Problem Description
It was reported that the patient had an initial left reverse total shoulder arthroplasty performed.The patient has had an arthroscopic debridement due to pain, stiffness, and decreased range of motion.After the surgery, the patient continued to have severe pain, instability, and was unable to perform usual activities.Small notching was noted at the most recent follow up.No exchange of product or further intervention has taken place to date.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
(b)(4) reported event was confirmed by review of medical records and radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Radiographs identified the following: very minimal scapular notching noted adjacent to the the inferomedial base of the inferior portion of the glenoid base plate, demonstrated by minimal amount of cortical erosion.The glenosphere and glenoid base plate along with the anchoring screws appear intact.The humeral component of the hardware appears unremarkable.No detected fracture or dislocation.Medical records identified the following: initial surgery noted no complications.Follow up noted moderate pain and instability, no x-ray findings.Further follow up noted severe pain and instability, x-rays were refused.There was bruising and stiffness over left biceps tendon, pain and decreased rom.Ct scan ordered to further evaluation, mri ordered for further evaluation, left shoulder arthroscopic debridement performed.Follow up noted severe pain and instability.Further follow up noted extreme pain, instability, unable to do usual activities (rom not measurable/unable).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.

• 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: 12232316
• Report Number: 0001825034-2021-02199
• Device Sequence Number: 11973835
• Product Code: PHX
• UDI-Device Identifier: 00880304475434
• UDI-Public: (01)00880304475434(17)240422(10)090740
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2024
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 090740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/04/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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; Other
• Patient Weight: 64