MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 14/150 STEM EXT TRL BOW; JRN : FEMORAL TRIALS

Catalog Number	298715214
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the paint is coming off the femoral trial.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for 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.However, if the product is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received, "when i clean this instrument the instruments release a lot of ¿blue paint¿ (see picture below)".The product was not returned to depuy synthes, however photo was provided for review.See attachment (image001).The photographs attached were reviewed, however no evidence was provided representing the current impacted product, therefore no further conclusion can be drawn of the reported device malfunction.The overall complaint was unconfirmed as the photographs provided are not representative of the reported impacted product.As part of depuy synthes 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿when i clean this instrument the instruments release a lot of ¿blue paint¿ (see picture below)¿ the products and photos (image001) were returned to depuy synthes for evaluation.The complaint unit was forwarded to the depuy material science lab in warsaw for further investigation.Further details of the device's analysis were attached on "material evaluation e2024-000878 (b)(4)".Visual analysis of the returned sample revealed that 14/150 stem ext trl bow exhibits varying degrees of fading of the blue anodizing and white chalky appearance on the surface.The observed white chalky appearance is consistent with corrosion of the aluminum alloy.These observations suggest the stem was exposed to a corrosive environment outside of what is permitted by the instructions for use (ifu-0902-00-721).The stem was likely exposed to basic or acidic solutions where ph is either high or very low, respectively, or to an electrolytic solution with high chloride concentrations.The overall complaint was confirmed as the observed condition of the stem ext trl bow would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to maintenance, 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 depuy synthes 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: 14/150 STEM EXT TRL BOW
• Common Device Name: JRN : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18267012
• Report Number: 1818910-2023-24574
• Device Sequence Number: 14473903
• Product Code: HWT
• UDI-Device Identifier: 10603295157908
• UDI-Public: 10603295157908
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/05/2023

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: 298715214
• Device Lot Number: AF1455295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 01/10/2024; 04/15/2024; 05/30/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/11/2023; 01/10/2024; 04/17/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown