MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 7 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-705
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	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent right attune tkr in another facility and under another surgeon on [date].Presented to this surgeon with complaint of anterior knee pain.On ct surgeon noted a hot spot under the patella and ? patella loosening.Revision procedure performed, surgeon put knee through a range of motion and noted laxity in both flexion and extension with existing 5mm poly insert.Surgeon removed this insert and trialed with 7mm insert and was satisfied with rom and stability in flexion and extension.A size 7/7mm definitive poly was inserted.Attention then turned to the patella.The surgeon was able to easily remove the patella component using a bristow elevator and remarked that there 'was only small amount of cement on both the bone and patella component' he proceeded to remove what cement remained, performed a clean up cut and resurfaced the patella to a 41mm dome patella.If other, describe: revision of patella component and poly exchange right attune tkr, was surgery delayed due to the reported event? no.Action taken when event occurred? revision of patella component and change of poly insert.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no.Is the patient part of a clinical study? no.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.If any new information will be made available, the additional information will be submitted through cst: true.
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.Review of the x-ray evidence found nothing indicative of a device nonconformance or relation of the product with the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 7 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17238695
• Report Number: 1818910-2023-13497
• Device Sequence Number: 7091151
• Product Code: NJL
• UDI-Device Identifier: 10603295047988
• UDI-Public: 10603295047988
• 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: 2021
• 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,Followup
• Report Date (Section B): 06/30/2023

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: 1516-30-705
• Device Catalogue Number: 151630705
• Device Lot Number: 9514535
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 07/02/2023; 07/24/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/07/2023; 07/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL ANAT PAT 35MM; DEPUY CMW 2G 20G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male