MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATU REV DST F AUGTRL 16XSZ9-10; KNEE INSTRUMENTS: FEMORAL AUGMENT TRIAL

Catalog Number	254709004
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the products show rusting and discolouration on products' information.The product damage has been identified during loan kit inspection by the loan kit technician.There are no surgeon, procedure, or patient details available.
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.H3, h6 investigation summary: the product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that 254709004, atu rev dst f augtrl 16xsz9-10 was rusted.The observed condition is likely caused due to cleaning/sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the atu rev dst f augtrl 16xsz9-10 would contribute to the complained device issue.Based on the investigation findings, potential cause can be 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 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.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 (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.H11 additional narrative: corrected data: e1 - initial reporter country code.
Event or Problem Description
Additional information received states that there are two trials.The product was not damaged just is rusting.
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: b5, d9.If information is obtained that was not available for the initial report, a follow-up report will be.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, " the product(s) shows rusting and discoloration on product(s) information.¿ the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that 254709004, atu rev dst f augtrl 16xsz9-10 was rusted.The observed condition is likely caused due to cleaning/sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the atu rev dst f augtrl 16xsz9-10 would contribute to the complained device issue.Based on the investigation findings, potential cause can be 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 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: 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).Investigation summary: the product(s) shows rusting and discolouration on product(s) information.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the atu rev dst f augtrl shows rusting.However, does not observed discoloration.Where corrosion patterns were observed, condition suggests that the passive layer of the metal has been worn down from repeated use (due to normal use damage and repeated cleaning sterilizations) allowing for the metallic surface underneath to become susceptible to corrosion/oxidation.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.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 atu rev dst f augtrl would contribute 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: 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.H11 additional narrative: added: d9.Corrected: h3.

• Brand Name: ATU REV DST F AUGTRL 16XSZ9-10
• Common Device Name: KNEE INSTRUMENTS: FEMORAL AUGMENT TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22019360
• Report Number: 1818910-2025-07817
• Device Sequence Number: 13114724
• Product Code: LXH
• UDI-Device Identifier: 10603295439608
• UDI-Public: (01)10603295439608(10)NW219210
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 254709004
• Device Lot Number: NW219210
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/26/2025; 06/04/2025; 06/11/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/14/2025; 05/28/2025; 06/05/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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