MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 12MM; KNEE TIBIAL INSERT

Model Number	1517-10-512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); Joint Laxity (4526)
Date of Event	11/30/2020
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
Patient initiated complaint received: it was reported that patient had an attune knee replacement and can¿t get knee to heal and surgery still not heal.Follow up conducted with further information provided: further information on 5-apr-2021.Patient states she originally had both knees replaced 20 years ago with parts of an unknown manufacturer.She was revised to depuy components due to loosening of the unknown manufacturer's parts.She had her left knee revised to depuy components on (b)(6) 2019 and the right revised to depuy components on (b)(6) 2019.Both knees have had significant pain and feels unstable.The left had an arthroscopy done on (b)(6) 2020 with no improvement.She has had injections in both knees without improvement in pain.Her xrays are "clear." she is planning to visit her surgeon this week to discuss another revision due to the pain.
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.

• Brand Name: ATTUNE CRS RP INSRT SZ 5 12MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11664230
• Report Number: 1818910-2021-07869
• Device Sequence Number: 3015131
• Product Code: JWH
• UDI-Device Identifier: 10603295055938
• UDI-Public: 10603295055938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 1517-10-512
• Device Catalogue Number: 151710512
• Device Lot Number: 8901591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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 5 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ATUN PRESSFIT STR STEM12X110MM.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE REV RP TIB BASE SZ 5 CEM.; SMARTSET GMV 40G US EO.; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention