MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi : (b)(4).Product has been received by zimmer biomet and 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 that the implant box was opened in the field and there was a hair was inside the internal package for the implant.The implant and box were removed from the field and nothing was implanted in the patient due to contamination.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product could not locate any foreign material.The packaging was opened and not all the packaging materials were returned.Complaint cannot be confirmed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product and the dhr review.A definitive root cause cannot 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: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10670047
• Report Number: 0001822565-2020-03499
• Device Sequence Number: 2605846
• Product Code: MBH
• UDI-Device Identifier: 00889024469372
• UDI-Public: (01)00889024469372
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512100910
• Device Lot Number: 64348503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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