MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 11MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION; PROSTHESIS, 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	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee procedure, the surgeon noted debris in the sterile packaging of the stem prosthesis.Another stem was used to complete the procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).G2 foreign source: finland 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event could not be confirmed.Visual examination of the returned product identified an unknown debris.The unknown debris was sent for analytical testing, which determined the debris is consistent with skin.As the packaging was previously opened, the source of the skin cannot be confirmed.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for the reported part and part lot combination.A definitive root cause cannot 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: NEXGEN 11MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19125244
• Report Number: 0002648920-2024-00108
• Device Sequence Number: 8330501
• Product Code: JWH
• UDI-Device Identifier: 00889024220959
• UDI-Public: (01)00889024220959(17)330305(10)65871115
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 00598801011
• Device Lot Number: 65871115
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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