MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 7 CEM; KNEE TIBIAL TRAY

Catalog Number	UNK ATTUNE KNEE TIBIAL TRAY
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.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 : 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 fixation surface of the attune rp tib base sz 7 cem presents a small amount of bone cement over the flat underside section.Furthermore, it is worth mentioning that the surface of the rotating platform presents sings of pitting and circular scratches, which are consistent with a third body debris becoming trapped between the articulating surfaces of the tibial base and insert.With the information available, there is no indication that a design or manufacturing issue has caused or contributed to the observed condition of the tibial base.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 [150680007 / 9776473] 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 rp tib base 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: (b)(4) parts.2) date of manufacture: 17-mar-2021, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 30-apr-2031, 5) ifu reference: 090200829.Device history review : a manufacturing record evaluation was performed for the finished device [150680007 / 9776473] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: ATTUNE RP TIB BASE SZ 7 CEM
• Common Device Name: KNEE TIBIAL TRAY
• 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: 19836930
• Report Number: 1818910-2024-16010
• Device Sequence Number: 18112247
• Product Code: NJL
• UDI-Device Identifier: 10603295492191
• UDI-Public: (01)10603295492191(17)310430(10)9776473
• 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
• Report Date (Section B): 07/26/2024
• 2 Devices were Involved in the Event: 1 2

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: UNK ATTUNE KNEE TIBIAL TRAY
• Device Lot Number: 9776473
• 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; 11/11/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/09/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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 FEM LT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 5MM; UNK ATTUNE KNEE TIBIAL INSERT; UNKNOWN KNEE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male