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 Problem Inflammation (1932)

Event Date 07/26/2019

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

Subject id: (b)(6).Study: (b)(6).Clinical adverse event received for pes bursitis.Event is not serious and is considered mild.Event is not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2015.Date of event (onset): (b)(6) 2019.(right hip).Treatment: medical intervention/ modification: cortisone injection in right pes bursa.

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.

Manufacturer Narrative

Product complaint # (b)(4).In reference to the submitted follow-up 1 report, the concomitant products were identified to be competitor products used in conjunction with the previously reported adverse event.

• 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: 11801055
• MDR Text Key: 249958686
• Report Number: 1818910-2021-09929
• 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: health professional,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 7920232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ 5 5MM; ATTUNE CR FB INSRT SZ 5 5MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; COMPETITOR BONE CEMENT; SIMPLEX CEMENT:61941001/424AA856CV
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 68