MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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
Medical records received 13 sep 2018.Records indicate patient received an attune tka.No allegations provided of patient injury or product failure, nor report of revision.The patient underwent a left total knee arthroplasty on (b)(6) 2015 utilizing depuy synthes components including patella resurfacing with a competitor cement with no complications.On (b)(6) 2016, she underwent a revision for aseptic failure of the left tka.Intraoperatively, extensive scarring was found.The surgeon required osteotomes to remove the femoral and tibial components and any indication of loosening was never stated.The surgeon states that 6 degrees of external rotation from the previous external rotation was cut to "improve the alignment of the femoral component." no other complications identified.Doi: (b)(6) 2015, dor: unknown (left).
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 : 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.

• Brand Name: ATTUNE PS RP INSRT SZ 5 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12474119
• Report Number: 1818910-2021-20114
• Device Sequence Number: 11663345
• Product Code: NJL
• UDI-Device Identifier: 10603295052487
• UDI-Public: 10603295052487
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• 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): 09/13/2018

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: 12/31/2018
• Device Model Number: 1516-50-514
• Device Catalogue Number: 151650514
• Device Lot Number: 7838363
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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 29MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; STRYKER BONE CEMENT; STRYKER BONE CEMENT; ATTUNE MEDIAL DOME PAT 29MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; STRYKER BONE CEMENT; STRYKER BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR