MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-035

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

Patient Problem Pain (1994)

Event Date 06/10/2020

Event Type  Injury  

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 Description

Clinical adverse event received for persisting pain.Event is not serious and is considered moderate.Event is probably related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2020.(left knee).Treatment: injected and oral medications (unspecified), physical therapy.

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 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11932740
• MDR Text Key: 261036855
• Report Number: 1818910-2021-11804
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 1518-20-035
• Device Catalogue Number: 151820035
• Device Lot Number: 9003236
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/18/2021
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 2MM.; ATTUN REV OFFST STM ADPTR 6MM.; ATTUNE CRS FB INSRT SZ 4 6MM.; ATTUNE CRS FEMORAL LT SZ 4 CEM.; ATTUNE DIST FEM AUG SZ 4 8MM.; ATTUNE DIST FEM AUG SZ 4 8MM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE POS FEM AUG SZ 4 4MM.; ATUNE CRS FB TIB BASE SZ 3 CEM.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE PRESSFIT STR STEM18X60MM.; PALACOS R+G:66017747/91194795.; PALACOS R+G:66017775/90445293.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88