MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 5 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-508
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a rp poly insitu which spun out twice and was unable to be reduced.Medial collateral ligament damaged (flexion gap loose with mid flexion instability).Revision surgery booked for conversion to attune revision crs with hinge option available.Prepared for attune revision however at trailing knee was still unstable with crs insert - lateral collateral stretched.Converted to srom hinge and gained stability.
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: the device associated with this report was not returned to depuy synthes for evaluation.Review of the returned x-rays found the femoral knee implant in inconsistent positions, consistent with an unintended rotation of the liner.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: ATTUNE CR RP INSRT SZ 5 8MM
• 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: 16005961
• Report Number: 1818910-2022-25733
• Device Sequence Number: 20238955
• Product Code: NJL
• UDI-Device Identifier: 10603295047773
• UDI-Public: 10603295047773
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/19/2022

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: 1516-30-508
• Device Catalogue Number: 151630508
• Device Lot Number: 9631058
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 02/18/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM RT SZ 5 NAR CEM; ATTUNE CR RP INSRT SZ 5 8MM; ATTUNE RP TIB BASE SZ 5 CEM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 82 KG