MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK 360 R FEM 80MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was used.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported upon opening the box the outer plastic blister was found to have a crack in it.The plastic rubbery bag around the femur also had a hole in it.Additionally, there was not a second sterile blister.Since no other replacement femur of the same size and side was available the hospital flashed sterilized this implant.It was then assembled with augments and a stem and implanted with bone cement.
Event or Problem Description
No additional information reported.
Additional Manufacturer Narrative
No product or packaging was returned, however, review of the picture provided identifies the cracked sterile cavity.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to transit damage; further investigation is being conducted through our capa process.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.

• Brand Name: VNGD SSK 360 R FEM 80MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9174460
• Report Number: 0001825034-2019-04608
• Device Sequence Number: 2614686
• Product Code: MBV
• UDI-Device Identifier: 00880304481985
• UDI-Public: (01)00880304481985
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 10/13/2025
• Device Model Number: N/A
• Device Catalogue Number: 185270
• Device Lot Number: 3657658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 02/07/2020
• 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