MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 29MM FULL POR; KNEE TIBIAL TRAY ACCESSORY

Catalog Number	151111201
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
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Study no: (b)(4).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: on (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.

• Brand Name: ATUN TIB SLV M/L 29MM FULL POR
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• 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 ; 3035526892
• MDR Report Key: 20407225
• Report Number: 1818910-2024-21156
• Device Sequence Number: 3379342
• Product Code: NJL
• UDI-Device Identifier: 10603295436553
• UDI-Public: (01)10603295436553(17)301130(10)J94Z36
• 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: 151111201
• Device Lot Number: J94Z36
• 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: 12/09/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 79 KG