MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THIN 37X8.6 3 PEG; PROSTHESIS, KNEE

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	05/12/2021
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.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 a hair that was found in packaging of an implant.There is no additional information available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d9, g3, g6, h1, h2, and h10 corrected: d4, h4.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual evaluation of the returned product identified that there is debris inside the sterile package that was opened.The dhr was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported item and lot combination.The condition of the product when it left zimmer biomet control cannot be determined.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.

• Brand Name: SERIES A PAT THIN 37X8.6 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11932927
• Report Number: 0001825034-2021-01714
• Device Sequence Number: 3080871
• Product Code: JWH
• UDI-Device Identifier: 00887868344169
• UDI-Public: (01)00887868344169(17)251008(10)903370
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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: 05/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 184788
• Device Lot Number: 979970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2021
• Supplement Date Received by Manufacturer: 06/24/2021; 08/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/01/2021; 08/16/2021
• 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