MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ C RM; KNEE PROSTHESIS

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	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that upon opening the implant, an eyelash was noticed in the sterile packaging.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, in this case no patient harm or further outcome was reported.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided picture does show some kind of black strand of material which may be a hair as reported however the quality of the photograph is not of a suitable definition to allow a better identification of what the strand is.It is noted that the packaging is opened with the particle on top of the foam, under the tyvek lid.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Based on the available information, the reported event cannot be confirmed in that it seems evident that there is a foreign material however its identity cannot be confirmed as a hair as reported and the packaging was opened before the strand was found which means that it is possible that it could have been introduced upon opening the packaging.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 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: OXF UNI CMNTLS TIB SZ C RM
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19674462
• Report Number: 3002806535-2024-00249
• Device Sequence Number: 7751117
• Product Code: NRA
• UDI-Device Identifier: 00887868354748
• UDI-Public: (01)00887868354748(17)330304(10)7395827
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 166575
• Device Lot Number: 7395827
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown