MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CRS RP INSRT SZ 7 14MM; PROSTHESIS, KNEE, MOBILE BEARING

Catalog Number	151710714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(4).Study no: dots it was reported from clinical study an adverse event received for knee revision on (b)(6) 2024 due to joint instability.Date of implant was (b)(6) 2022.
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.H11 additional narrative: added: b5, d10 (concomitant), h6 (health effect - clinical code).
Event or Problem Description
Medical records review received and stating that: the right total knee was revised on (b)(6) 2024, to address a painful right knee, secondary to flexion instability.This was now the patient's second revision, to address the same symptoms the patient had been revised conservatively for two years earlier.The surgeon explanted the femur, tibial tray, and tibial insert, and replaced them with revision components.The patient's patella was retained.Updated event description: clinical adverse event received for knee revision due to instability device related: no information provided procedure related: no information provided.Date of event: september 17, 2024.Date of implant: on (b)(6) 2022.Date of revision: on (b)(6) 2024.Device location: right.Treatment/impact: blood thinners (aspirin) and ted hose.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint record is approved to be converted to an npi on 04 december 2024).There is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device.The reported event is not related to device nor procedure and therefore does not meet the definition of a complaint as t was determined that the revision on (b)(6) 2022 was of competitor products and the second revision on (b)(6) 2024 was also of competitor products.Attune revision parts were placed during the (b)(6) 2024 but there are no current allegations against these products and therefore the products will be updated to npi and us fda mdr decision downgraded to not reportable.

• Brand Name: ATTUNE CRS RP INSRT SZ 7 14MM
• Common Device Name: PROSTHESIS, KNEE, MOBILE BEARING
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20428232
• Report Number: 1818910-2024-21405
• Device Sequence Number: 7627311
• Product Code: NJL
• UDI-Device Identifier: 10603295056164
• UDI-Public: (01)10603295056164(17)271130(10)4019697
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 151710714
• Device Lot Number: 4019697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/11/2024; 12/04/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/23/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2022
• 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 CRS FEMORAL RT SZ 7 CEM.; ATUNE REV RP TIB BASE SZ 7 CEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White