MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP TIB BASE SZ 3 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611003
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that when opened a tibial base tray new in the box.Scrub tech noticed a hair like piece inside the sterile packaging.Handed implant back and a new tibial implant was opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d4 (lot, expiry date), d9, h4.Corrected: d4 primary udi number.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary it was reported that opened a tibial base tray new in the box.Scrub tech noticed a hair like piece inside the sterile packaging.Handed implant back and a new tibial implant was opened.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the package of the attune rp tib base sz 3 por displays signs of manipulation and the blister is opened.A foreign matter can be seen taped on the white protective cover.It is reasonable to suspect that this foreign matter may have compromised the sterility of the product.A manufacturing record evaluation was performed for the finished device product code: 150611003 lot number: 4016990, and there were 4 non-conformances associated with this lot, however these are not related to the failure mode of the complaint.The reported allegation can be confirmed, however since the blister have been opened, it cannot be confirmed whether the foreign matter was present within the sterile package when it left j&j's control or at what point the package may have been exposed to this foreign matter.Evidence indicates that the device had been properly sealed and packaged at the manufacturer before it was opened.Consequently, there is no indication of any manufacturing error that could have contributed to the reported issue.Without concrete evidence or further information, it is not possible to determine a root cause.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune rp tib base sz 3 por would have contributed to the complained 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 product code: 150611003 lot number: 4016990, and there were 4 non-conformances associated with this lot, however these are not related to the failure mode of the complaint.Device history batch null.Device history review a manufacturing record evaluation was performed for the finished device product code: 150611003 lot number: 4016990, and there were 4 non-conformances associated with this lot, however these are not related to the failure mode of the complaint.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE RP TIB BASE SZ 3 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19566601
• Report Number: 1818910-2024-13252
• Device Sequence Number: 6963375
• Product Code: NJL
• UDI-Device Identifier: 10603295416258
• UDI-Public: (01)10603295416258(17)321130(10)4016990
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2024

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 Catalogue Number: 150611003
• Device Lot Number: 4016990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 02/14/2025; 03/05/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/05/2024; 02/18/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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 Age: 72 YR
• Patient Sex: Unknown