MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER SEGMENTAL SYSTEM FLUTED STEM EXT. STRAIGHT PRECOAT; PROSTHESIS, KNEE

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	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 foreign source: canada 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
It was reported that during a knee procedure, it was noted that the sterile packaging of the stem prosthesis was compromised upon opening.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were.Updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.H6: device not returned, operational problem identified, cause not established are n/a which was reported on initial report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows carton had been previously opened and exhibits damage, the sealed cavities showed stress marks with both cavities, inner and outer had cracked.The sterility had been compromised.The root cause of the reported event can be attributed to transit damage.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.

• Brand Name: ZIMMER SEGMENTAL SYSTEM FLUTED STEM EXT. STRAIGHT PRECOAT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19577050
• Report Number: 0001822565-2024-02084
• Device Sequence Number: 3980736
• Product Code: KRO
• UDI-Device Identifier: 00889024197763
• UDI-Public: (01)00889024197763(17)311108(10)65245127
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2025

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: 00585205015
• Device Lot Number: 65245127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 05/09/2025
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/25/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown