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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant products: item#115370; lot# 104630; comp rvs tray co 44mm.Item#113632; lot# 64864899; comp primary stem 12mm mini.Item# 405889; lot# 834620; comp rvs 2.7mm dia drl.Item# 405800; lot# 523080; comp.Rev shldr 9 in steinmann.Item# 115396; lot# 692590; comp rvs cntrl 6.5x30mm st/rst.Item# 010000589; lot# 709750; comp rvrs 25mm bsplt ha+adptr.Item# 180550; lot# 508960; comp lk scr 3.5hex 4.75x15 st.Item# 180552; lot# 277230; comp lk scr 3.5hex 4.75x25 st.Item# 180558; lot# 130890; comp nlk scr 3.5hex 4.75x20 st.Item# 115310; lot# 903670; comp rvrs shldr glnsp std 36mm.Report source: foreign: event occurred in (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the polyethylene standard bearing did not fit the comprehensive humeral tray during surgery.As a result, a +3mm polyethylene bearing was used to complete the surgery.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned bearing identified damage to it from impaction to the tray.Medical records were not provided.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: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11744733
• Report Number: 0001825034-2021-01053
• Device Sequence Number: 4357410
• Product Code: KWS
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)250709(10)792350
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 792350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE