MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	05/06/2020
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
On (b)(6) 2020, the patient had a revision right total knee arthroplasty, entire femoral and tibial component to address painful right knee arthroplasty with osteolysis.During the revision, the surgeon noted a fair amount of bone loss around the tibial side also some micro motion on the tibial side.The loosening was noted at the bone/cement interface of the tibial side.The femoral side was noted to be well fixed, but was revised nonetheless.The patella component was well fixed and not revised.Competitor components were implanted during this revision.Doi: (b)(6) 2016 (femur), doi: (b)(6) 2019 (tibia, insert and patella - first revision captured in (b)(4)), dor: (b)(6) 2020.
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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS RP INSRT SZ 8 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11046346
• Report Number: 1818910-2020-27315
• Device Sequence Number: 1194234
• Product Code: NJL
• UDI-Device Identifier: 10603295052913
• UDI-Public: 10603295052913
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 02/29/2020
• Device Model Number: 1516-50-816
• Device Catalogue Number: 151650816
• Device Lot Number: 8079913
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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 16MM; ATUN PRESSFIT STR STEM18X110MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE REV RP TIB BASE SZ 6 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 16MM; ATUN PRESSFIT STR STEM18X110MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE REV RP TIB BASE SZ 6 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR