MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 7 CEM; KNEE FEMORAL

Catalog Number	150410107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Planned inlay revision of ps-attune-knee-tep left side after about one year of implantation because patient had issues stretching the knee.Intraoperatively the pe-inlay showed strange scratches.Surgeon decided to change complete knee-tep to a competitor product.
Additional Manufacturer Narrative
Product complaint # : (b)(4).D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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).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.Added: d4 (catalog), d9, g4 (pma/ 510(k).Corrected: d1, d2a, d4 (primary udi number), d10 (concomitant).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).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 reconstruction, or its employees caused or contributed to the potential event described in this report.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 received, ¿planned inlay revision of ps-attune-knee-tep left side after about one year of implantation because patient had issues stretching the knee.Intraoperatively the pe-inlay showed strange scratches.Surgeon decided to change complete knee-tep to a competitor product¿.The product returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the majority of the fixation surface of the attune ps fem lt sz 7 cem was covered with bone cement with good cement-to-bone interdigitation.Furthermore, scratches were observed on the articulating surface, consistent with constant articulation with the mating implants and third-body debris trapped between the articulating surfaces.With the information available, there is no indication that a design or manufacturing issue has caused or contributed to the observed condition of the femoral component.Therefore, it is not possible to determine a potential cause at this moment for the observed pitting and scratches.However, in support of the evaluation performed, it is suspected that the third body wear was caused by bone cement.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [150410107 / 9801215] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune ps fem lt sz 7 cem would contribute to the reported adverse event 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 1) quantity manufactured: 11 parts.2) date of manufacture: 01-june-2021 3) any anomalies or deviations identified in dhr: no manufacturing irregularities related to the malfunction were observed.4) expiry date: 31-may-2031 5) ifu reference: 090200828 device history review a manufacturing record evaluation was performed for the finished device [150410107 / 9801215] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE PS FEM LT SZ 7 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19836932
• Report Number: 1818910-2024-16011
• Device Sequence Number: 7877558
• Product Code: JWH
• UDI-Device Identifier: 10603295041641
• UDI-Public: (01)10603295041641(17)47999(10)9801215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150410107
• Device Lot Number: 9801215
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 10/09/2024; 11/11/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/09/2024; 10/14/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS RP INSRT SZ7 5MM; ATTUNE RP TIB BASE SZ 7 CEM; UNK ATTUNE KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male