MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ5 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Study no:(b)(6).Clinical adverse events received for knee stiffness device and procedure(relatedness) device related: definitely procedure related: definitely date of event: 16 sep 2024 date of implant: (b)(6) 2023 date of revision: no information provided device location: left treatment/impact: physical therapy depuy synthes product used: component type: femoral component catalog number: 150410105 lot number id: 3851774 description: no information provided component type: tibial base component catalog number: 150680006 lot number id: 4022166 description: no information provided component type: tibial stem catalog number: 151310110 lot number id: j8383w description: no information provided component type: tibial sleeve catalog number: 151111201 lot number id: j94z36 description: no information provided component type: tibial insert component catalog number: 151650505 lot number id: 3787761 udi:(b)(4).Component type: cement catalog number: 3003940002 lot number id: ax42ak0b03 description: no information provided.
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.

• Brand Name: ATTUNE PS RP INSRT SZ5 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20407149
• Report Number: 1818910-2024-21154
• Device Sequence Number: 14347410
• Product Code: NJL
• UDI-Device Identifier: 10603295052425
• UDI-Public: (01)10603295052425(17)270430(10)3787761
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 151650505
• Device Lot Number: 3787761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2022
• 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: UNK BONE CEMENT 3003940002, AX42AK0B03
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 79 KG