MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-407
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, the patient underwent the primary surgery via tka for left knee oa with the insert 7mm in question.The surgery was completed successfully without any surgical delay.1 week after the surgery, the insert in question came off.Attempted manual reduction was unsuccessful.On (b)(6) 2023, the revision surgery was done.After initial opening procedure, the following conditions were observed.It was confirmed that the insert had rotated 90°.Her lateral collateral ligament was loose, and the tibial attachment of the patellar ligament was fractured avulsion.The tibial attachment of the patellar ligament was repaired with a high-strength suture.As a result of trial reduction with an insert trial, the tendency to prolapse was subsided with an insert of 12 mm thickness, so a 12 mm thick implant was re-replaced.The revision surgery was completed successfully without any surgical delay.As the cause of this event after primary surgery, it is possible that the flexion gap was loose during the primary surgery, but the selection of the insert with a thin 7mm made it easy to come off.In addition, the patient's delirium progressed after the primary surgery, and it is possible that the insert dislocated due to the unreasonable posture without being able to keep the restricted limb position.The surgeon also left the following comment: although he has never experienced a prolapse when using lcs, he was also concerned about the impact of attune's implant design.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ATTUNE CR RP INSRT SZ4 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16436407
• Report Number: 1818910-2023-04456
• Device Sequence Number: 15315903
• Product Code: NJL
• UDI-Device Identifier: 10603295047643
• UDI-Public: 10603295047643
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 02/24/2023

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 Model Number: 1516-30-407
• Device Catalogue Number: 151630407
• 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: 01/29/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female