MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Impaired Healing (2378); Joint Laxity (4526)

Event Date 11/30/2020

Event Type  Injury  

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 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 (b)(6) 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.

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 MEDIAL DOME PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11664225
• MDR Text Key: 245370010
• Report Number: 1818910-2021-07868
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056690
• UDI-Public: 10603295056690
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-20-038
• Device Catalogue Number: 151820038
• Device Lot Number: 9307880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL LT SZ 5 CEM.; ATTUNE CRS RP INSRT SZ 5 12MM.; 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 CRS RP INSRT SZ 5 12MM; 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
• Patient Outcome(s): Required Intervention