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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: item# 115310; lot# 399390; comp rvrs shldr glnsp std 36mm.Item# 115330; lot# 558080; comp rvrs shdr glen bsplt +ha.Item# 180555; lot# 480960; comp lk scr 3.5hex 4.75x40 st.Item# 180558; lot# 599120; comp nlk scr 3.5hex 4.75x20 st.Item# 115396; lot# 185690; comp rvs cntrl 6.5x30mm st/rst.Item# 180554; lot# 420250; comp lk scr 3.5hex 4.75x35 st.Item# 118001; lot# 396600; versa-dial/comp ti std taper.Item# 115345; lot# 855450; comp rvs hmrl ti tray+5mm 44mm.Report source: foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.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: 0001825034-2021-00769.
Event or Problem Description
It was reported that patient underwent a revision procedure due to dislocation, seven days after the initial procedure.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs provided noting a reverse total shoulder arthroplasty with presumed anterior dislocation of the humeral component.No definite fracture is seen and bone quality appears normal.The ac joint is intact.Visual examination of the provided pictures identified the bearing attached to the tray with blood remnants on it.A picture of the glenosphere were not provided.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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
The received additional information does not change the final conclusions of previous investigation.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• Common Device Name: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11602514
• Report Number: 0001825034-2021-00768
• Device Sequence Number: 4266508
• Product Code: KWS
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)250113(10)274480
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193373
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 01/13/2025
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 274480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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; Required Intervention