MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION OFFSET LONG; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information provided by the customer.Visual inspection of the returned product found that the product was not returned in the packaging.Visual evaluation of the returned device found no visible damage.Dhr was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet is unable to be determined as the product returned without the packaging.The root cause is unable to be determined.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 during a knee procedure, the product packaging was compromised and partially open.The surgeon used a different product to complete the surgery.There was no direct contact with the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: STEM EXTENSION OFFSET LONG
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12056915
• Report Number: 0001822565-2021-01725
• Device Sequence Number: 4203111
• Product Code: JWH
• UDI-Device Identifier: 00889024221567
• UDI-Public: (01)00889024221567(17)280331(10)63932074
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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 Model Number: N/A
• Device Catalogue Number: 00598802116
• Device Lot Number: 63932074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/24/2021
• 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