MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC HD ARCOM XL 28X42MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis product was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that there was a hair found in the packaging.Attempts have been made and additional information on the reported event is unavailable at this time.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined as the product was not returned, and no photos were provided for evaluation.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.

• Brand Name: ACT ARTIC HD ARCOM XL 28X42MM
• Common Device Name: PROSTHESIS, HIP
• 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: 12870094
• Report Number: 0001825034-2021-03180
• Device Sequence Number: 3547650
• Product Code: LPH
• UDI-Device Identifier: 00880304491342
• UDI-Public: (01)00880304491342(17)250403(10)254610
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: 04/03/2025
• Device Model Number: N/A
• Device Catalogue Number: XL-200148
• Device Lot Number: 254610
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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
• 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
• Patient Sex: Unknown