MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, SHORT, 115 MM; IMPLANT, TRAUMA

Catalog Number	0202263000
Medical Device Problem Codes	Unsealed Device Packaging (1444); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an initial procedure that the jumper used a small cutter knife to slightly cut the foil wrapping on the packaging.The foil was undamaged and tightly enclosed the entire paper carton.The jumper then removed the well-adhering cardboard seal so that the contents could be removed.Here, too, everything was as usual.The seal was tight.Then, wanted to open the peel-off packaging at the intended point, when the instrument technician said that the packaging is already open cause the upper packaging could simply be folded back, without adhesion, sticking to the side edges.On closer inspection, there was a small stain on the outside of the already open paper lid and brownish stains all over the inside of the plastic packaging, similar to dried blood.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).G2.Report source: germany.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, e1, g3, g6, h2, h3, h6, h11.Upon product return, it was observed that both the internal and external blisters had their tyvek lids removed.Red stains, which appear to be blood, were found on the tyvek lids as well as on the surfaces of the blisters.The plate remains inside the internal blister and is still in its pouch, but it is no longer in its original configuration.Notably, the plastic retainer was not returned with the product.The glue on the sealing areas that connect the blisters and the tyvek lid appear compact and uniform, with no irregularities.The outer blister remains clean, with minimal to no staining, while the inner blister is stained.The pouch containing the product is also clean.A review of the device manufacturing records confirmed no abnormalities or deviations.At the end of the packaging process, a 100% visual inspection of all pieces of the lot was performed and found no issue.Internal process at a return center was also reviewed.Based on the reviews performed, it is unlikely that the product left zimmer biomet in a non-conforming state.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.The glue on the sealing areas between the blisters and the tyvek lid appears compact and uniform, with no irregularities.This suggests that the product was sealed correctly during manufacturing, ruling out a sealing or packaging defect during manufacturing as the cause.The outer blister and the pouch are clean, with no or minimal staining, while the inner blister is stained.This likely indicates that the product was handled and contaminated in an operating room, rather than during any internal process.Nevertheless, with the available information, the reported problem could not be reproduced during investigation and a definitive root cause cannot be established.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: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, SHORT, 115 MM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21402904
• Report Number: 0009613350-2025-00068
• Device Sequence Number: 20912259
• Product Code: HRS
• UDI-Device Identifier: 00889024480018
• UDI-Public: (01)00889024480018(17)320131(10)3098298
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Catalogue Number: 0202263000
• Device Lot Number: 3098298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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