MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEMMED TIBIAL COMPONENT PRECOAT SIZE 5; IMPLANT, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
After opening the properly sealed external packaging, it was noted the implant was not correctly contained inside the inner sterile packaging.There was no patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of a photograph.Visual evaluation of the provided photo found the inner and outer blister seals have been breached with residual adhesive transfer present, and therefore, the sterility has been breached.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: STEMMED TIBIAL COMPONENT PRECOAT SIZE 5
• Common Device Name: IMPLANT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12669775
• Report Number: 0001822565-2021-03061
• Device Sequence Number: 15391817
• Product Code: JWH
• UDI-Device Identifier: 00889024217607
• UDI-Public: (01)00889024217607(17)310118(10)J6947896
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 00598004701
• Device Lot Number: J6947896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown