MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X12 X 12; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the provided images showed white unknown debris within an open sterile cavity.However, this cannot verify the reported event.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the product when leaving zimmer biomet cannot be verified.A definitive root cause cannot 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.Report source: event occurred in (b)(6).
Event or Problem Description
It was reported that during an initial tka, the packaging for the device was opened and the surgeon identified white particles inside the sterile blister.The device was implanted into the patient and packaging not returned.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, h10 d4: udi #(b)(4) packaging returned (cavity only).Visual inspection shows that packaging sterile blister(cavity) has white debris within the bottom and sides.This was identified during surgery the same implant was used to complete the surgery.Review of complaint history found additional related issues for this/these item(s) and the reported part and lot combination(s).Review of the returned product identified that there is white debris inside the sterile cavity that is consistent with tyvek lid abrading during transit that has been addressed.However, the tyvek lid has not been returned to verify abrasion.Root cause remains unchanged.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
No further event information available at the time of this report.

• Brand Name: E1 VNGD PS TIB BRG 71/75X12 X 12
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9723201
• Report Number: 0001825034-2020-00726
• Device Sequence Number: 367181
• Product Code: JWH
• UDI-Device Identifier: 00880304465701
• UDI-Public: (01)00880304465701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-183642
• Device Lot Number: 704940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1