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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 465470, catalog #: 106021, ringloc+ replacement ring sz21, lot # 462800, catalog #: 115378, comp rvs tray +10mm co 44mm, lot # 985550.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00327.Discarded.
Event or Problem Description
It was reported that patient underwent shoulder revision approximately 3 months ago.Subsequently, patient was revised again about 2 months later due to dislocation.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, g4, h1, h2.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.
Event or Problem Description
It was further reported that the patient had an initial left reverse total shoulder arthroplasty subsequently, the patient underwent revision due to dislocation five months post primary implantation.Finally the patient reported persistent instability in the shoulder post-revision as well as some persistent drainage.The drainage cultures were negative for infection, and the patient underwent a second revision one month post first revision.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was considered confirmed as the medical and operation notes noted impaired healing, instability, and dislocation.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARCOM XL 44-36 RTNV+3 HMRL BRG
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9612463
• Report Number: 0001825034-2020-00325
• Device Sequence Number: 19502388
• Product Code: KWS
• UDI-Device Identifier: 00880304475519
• UDI-Public: (01)00880304475519
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

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: 06/08/2023
• Device Model Number: N/A
• Device Catalogue Number: XL-115365
• Device Lot Number: 780540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 01/16/2020; 06/09/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/05/2020; 06/18/2020
• 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
• Patient Weight: 104