MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 72.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - (b)(6).Visual inspection of the returned product found the outer packaging was damaged.The label on the inner packaging was damaged.Additionally, a puncture in both layers of the tyvek sterile barriers was identified.Sterility of the device has been compromised.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.These products were likely conforming when they left zimmer biomet control.The root cause of the reported event can be attributed to transit damage.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
It was reported that the incoming inspection team member found the outer package was crushed and the product label was torn off.There is no additional information available at this time.

• Brand Name: VANGUARD CR ILOK FEM-LT 72.5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10314564
• Report Number: 0001825034-2020-02922
• Device Sequence Number: 11321320
• Product Code: JWH
• UDI-Device Identifier: 00880304449183
• UDI-Public: (01)00880304449183
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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 Model Number: N/A
• Device Catalogue Number: 183033
• Device Lot Number: J6462078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/23/2020
• 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