MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 8 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: dots clinical adverse event received for patellar tendon rupture, extensor mechanism insufficiency.Device and procedure (relatedness) remote possibility related to device, and possibly related to procedure.Date of event: (b)(6) 2024.Date of implant: information not provided.Date of revision: information not provided.Device location: right.Treatment/impact: revision additional event information: medical records (b)(4) clinical note ad on (b)(6) 2024) reviewed: on (b)(6) 2024, patient was seen in office for follow-up visit.Patient presented with obvious complete patella tendon rupture.Patient was having his right knee give out daily, with one instance of actually falling.Radiographs showed clear patella alta.Patient will be scheduled for a surgical patella tendon repair using allograft.
Additional Manufacturer Narrative
Product complaint (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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.If additional information is made available, the investigation will be updated as applicable.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.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.

• Brand Name: ATTUNE CR FEM RT SZ 8 CEM
• Common Device Name: ATTUNE IMPLANT : 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: 20006183
• Report Number: 1818910-2024-17627
• Device Sequence Number: 14590466
• Product Code: JWH
• UDI-Device Identifier: 10603295041238
• UDI-Public: (01)10603295041238(17)331130(10)D23122916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 150400208
• Device Lot Number: D23122916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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 CEMENTED STEM 14X30MM; ATTUNE MEDIAL DOME PAT 41MM; ATUNE CR RT MS INS SZ 8 16; ATUNE CRS FB TIB BASE SZ 8 CEM; DEPUY CMW 1 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 79 KG