MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG MOD TIB TRAY CEM COCR 3; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	158130000
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported when the scrub team was prepping for a tibia repair, the implant packaging had a foreign object of a red spec inside.Although this red spec was on the outer part of the polystyrene and not touching the actual implant, the consultant did not want to use it in case of risk of infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: i recently covered a case at hospital and upon the scrub team opening a tibia, the packaging inside had a foreign object of a red spec inside.Although this red spec was on the outer part of the polystyrene and not touching the actual implant, the consultant did not want to use it in case of risk of infection.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.A manufacturing investigation was performed by the j&j medtech orthopaedics suzhou team.The photo investigation revealed a red foreign matter on the white foam.It is worth mentioning that the foreign matter does not contact with the sig mod tib tray cem cocr 3.A manufacturing record evaluation was performed for the finished device [158130000/ d24104055], and no non-conformances or manufacturing irregularities were identified.Since the package had been opened and displays signs of manipulation, it cannot be confirmed whether the foreign matter was present within the package when it left j&j's control.Evidence indicates that the product had been properly sealed and packaged at the manufacturer before it was opened.Consequently, there is no indication that a design or manufacturing issue has caused the reported complaint condition.Once the product leaves j&j medtech orthopaedics control, it is unknown what environmental/external factors the finished goods products are exposed to.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the sig mod tib tray cem cocr 3 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device [158130000/ d24104055], and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device [158130000/ d24104055], and no non-conformances or manufacturing irregularities were identified.

• Brand Name: SIG MOD TIB TRAY CEM COCR 3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21291741
• Report Number: 1818910-2025-01930
• Device Sequence Number: 13061225
• Product Code: JWH
• UDI-Device Identifier: 10603295064893
• UDI-Public: (01)10603295064893(17)341031(10)D24104055
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032151
• 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

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: 158130000
• Device Lot Number: D24104055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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