MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 7 24MM; KNEE TIBIAL INSERT

Model Number	1517-10-724
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Revision of left attune revision total knee replacement.Patient underwent revision of left total knee replacement on (b)(6) 2021 to attune revision prosthesis, rp with stems and sleeves to both the tibia and femur.The patient has an underlying condition called charcot-marie-tooth disorder.Patient presented back to surgeon with instability and hyperextension of his left knee.Procedure performed today was revision of left attune revision prosthesis to lps distal femoral replacement.The tibial construct was assessed to be stable and was not revised.The femoral construct of femur, sleeve and stem was revised and a distal femoral replacement prosthesis was inserted.
Event or Problem Description
Additional information received indicated that there was no revision procedure for this patient on (b)(6) 2020.The procedure that took place for this patient on (b)(6) 2020 was the primary procedure not a revision.
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 CRS RP INSRT SZ 7 24MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12269315
• Report Number: 1818910-2021-16881
• Device Sequence Number: 14545635
• Product Code: NJL
• UDI-Device Identifier: 10603295056218
• UDI-Public: 10603295056218
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2021

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: 1517-10-724
• Device Catalogue Number: 151710724
• Device Lot Number: 8762789
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/31/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/26/2021; 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL LT SZ 7 CEM.; ATTUNE CRS RP INSRT SZ 7 24MM.; ATTUNE DIST FEM AUG SZ 7 4MM.; ATUN FEM SLV M/L 30MM HALF POR.; ATUN TIB SLV M/L 29MM HALF POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE PRESSFIT STR STEM16X60MM.; ATUNE REV RP TIB BASE SZ 8 CEM.; COMPETITOR CEMENT.; ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 24MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR