MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM RT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410205
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during tkr nurse opened definitive femur and noted that the packaging was warped.Surgeon was notified and was not confident about the sterility of the product.Another implant of the same size was available and opened to use.The surgery was delayed by a 1 minute.The procedure was successfully completed.There was no patient consequence.
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 that 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 recon described in this report.H11 additional narrative: added : d9, h6 (medical device problem code).If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information provided: "during tkr nurse opened definitive femur and commented on how the packaging was warped.Surgeon was notified and was not confident in the sterility of the product.We had another implant of the same size so opened and used that instead".The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed both blisters deformed and the tyvek lid open from the packaging, as a consequence of the deformation.Furthermore, based on the warped condition of the blisters, the sterility issue can be confirmed.Although the packaging is observed in a deformed/warped condition, no evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Per a previous data review activity completed in q1 2023 related to deformed/melted blister packaging, the potential cause of the deformed/melted blister packaging, cannot be traced to manufacturing or other jnj controlled facilities through which finished goods are distributed.Once the product leaves j&j medtech orthopaedics control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to exposer to extreme temperature conditions outside of j&j medtech orthopaedics control.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 attune ps fem rt sz 5 cem would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage, and 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 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 search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information provided: "during tkr nurse opened definitive femur and commented on how the packaging was warped.Surgeon was notified and was not confident in the sterility of the product.We had another implant of the same size so opened and used that instead".The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed both blisters deformed and the tyvek lid open from the packaging, as a consequence of the deformation.Furthermore, based on the warped condition of the blisters, the sterility issue can be confirmed.Although the packaging is observed in a deformed/warped condition, no evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Per a previous data review activity completed in q1 2023 related to deformed/melted blister packaging, the potential cause of the deformed/melted blister packaging, cannot be traced to manufacturing or other jnj controlled facilities through which finished goods are distributed.Once the product leaves j&j medtech orthopaedics control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to exposer to extreme temperature conditions outside of j&j medtech orthopaedics control.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 attune ps fem rt sz 5 cem would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage, and 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 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 search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information provided: "during tkr nurse opened definitive femur and commented on how the packaging was warped.Surgeon was notified and was not confident in the sterility of the product.We had another implant of the same size so opened and used that instead".The product was returned to medtech orthopaedics for evaluation.Visual inspection of the attune ps fem rt sz 5 cem revealed the following conditions on the device surface: 1) outer box with signs of opening; 2) both blisters deformed; 3) the tyvek lid completely open from the packaging, as a consequence of the deformation; 4) the un-used implant was returned for evaluation.Based on the warped condition of the blisters, the sterility issue can be confirmed.Although the packaging was returned in a deformed/warped condition, evidence suggests the device had been sealed and packaged correctly at the manufacturer prior to when it was opened by customer.Therefore, no evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Per a previous data review activity completed in q1 2023 related to deformed/melted blister packaging, the potential cause of the deformed/melted blister packaging, cannot be traced to manufacturing or other j&j controlled facilities through which finished goods are distributed.Once the product leaves j&j medtech orthopaedics control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to exposer to extreme temperature conditions outside of j&j medtech orthopaedics control.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps fem rt sz 5 cem would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage, and 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 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 search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE PS FEM RT SZ 5 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23075414
• Report Number: 1818910-2025-16044
• Device Sequence Number: 18641154
• Product Code: JWH
• UDI-Device Identifier: 10603295041764
• UDI-Public: (01)10603295041764(17)350531(10)4792789
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,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: 150410205
• Device Lot Number: 4792789
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 10/03/2025; 10/07/2025; 10/13/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/02/2025; 10/06/2025; 10/08/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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