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)
Date of Event	09/21/2020
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) 2016, the patient received a right attune total knee to treat osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.On (b)(6) 2020, the patient received a right knee revision to address scar removal, severe femoral and tibial bone loss, and tibial tray loosening and migration.The femoral component was noted to be well-fixed with no mention of migration.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.The patient was revised with depuy products and cement along with a competitor tibial cone.There were no indicated intra-operative complications.Doi: (b)(6) 2016; dor: (b)(6) 2020; right knee.
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: 11752991
• Report Number: 1818910-2021-09260
• Device Sequence Number: 16941994
• Product Code: NJL
• UDI-Device Identifier: 10603295052487
• UDI-Public: 10603295052487
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 05/31/2020
• Device Model Number: 1516-50-514
• Device Catalogue Number: 151650514
• Device Lot Number: 8107427
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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 38MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR