MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FRONT LOADING CARTRIDGE KIT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign: country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565 - 2022 - 02142.
Event or Problem Description
It was reported upon inspection in the japan warehouse, team member found debris in sterile package.No patient involvement.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.Complaint sample was evaluated and the reported event was confirmed.Visual review for front loading cartridge kit compatible with vacuum mixing system each individually sterile packaged [item 00506905200 lot 65451629] confirms (2) cavities had a loose dark debris in the sealed inner cavity.Both pieces were less than.60 sq.Mm.Per procedure a total of two particles whose individual areas do not exceed 0.60 sq.Mm in size are acceptable.Therefore, the devices are considered conforming.Device history record (dhr) was reviewed and no discrepancies were found.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the product when it left zimmer biomet was conforming.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
Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.

• Brand Name: FRONT LOADING CARTRIDGE KIT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15053702
• Report Number: 0001822565-2022-02141
• Device Sequence Number: 4772679
• Product Code: FZX
• UDI-Device Identifier: 00889024376670
• UDI-Public: (01)00889024376670(17)270330(10)65451629
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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 Model Number: N/A
• Device Catalogue Number: 00506905200
• Device Lot Number: 65451629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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