MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient received a right attune total knee to treat end-stage arthritis.The patella was resurfaced and unknown cement was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address a grossly infected right knee.The procedure was a stage-one of a two-stage plan to treat chronic osteomyelitis of the tibia, femur, and patella.There was a noted large prepatellar abscess infectious collection with skin necrosis, wound measuring approximately 3 x 5 cm., and erosion of bone.The tibial tray and patellar component were both loose at the cement to implant interface.There was also synovitis and adhesions.All components were removed.A competitor antibiotic spacer and products were implanted as part of the stage-one procedure.Doi: (b)(6) 2014, dor: (b)(6) 2018 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.E3 initial reporter occupation: lawyer.

• Brand Name: ATTUNE PS RP INSRT SZ 8 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11385513
• Report Number: 1818910-2021-03890
• Device Sequence Number: 14419315
• Product Code: NJL
• UDI-Device Identifier: 10603295052869
• UDI-Public: 10603295052869
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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 Expiration Date: 10/31/2017
• Device Model Number: 1516-50-807
• Device Catalogue Number: 151650807
• Device Lot Number: 3532225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/31/2021
• 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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 7MM; ATTUNE RP TIB BASE SZ 7 CEM; BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO); UNK MANUFACTURER TIBIAL INTERFERENCE SCREW; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 7MM; ATTUNE RP TIB BASE SZ 7 CEM; BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO); UNK MANUFACTURER TIBIAL INTERFERENCE SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR