MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer (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 received a primary left attune and to treat pain secondary to osteoarthritis.The patella was resurfaced and depuy cement x 3 was utilized.There surgeon notes there was severe tricompartmental articular cartilage loss.The procedure was completed without complications.Patient received a left knee revision to treat tibial pain and walking difficulty secondary to acute and chronic inflammation.Upon entering the joint, the surgeon identified and debrided significant grey tinged pseudo synovium, synovitis, and dense fibrosis.Pathology of the excised synovium identified acute and chronic inflammatory markers indicating hypersensitivity and foreign body reaction.Pathology reports did not confirm the presence of infection.The surgeon decided to revise all components to a depuy antibiotic spacer.There were no reported product defects for the patella, femoral component, tibial tray, or tibial insert.The procedure was completed without complications.Doi: (b)(6) 2017, dor: (b)(6) 2018, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE PS RP INSRT SZ9 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10234212
• Report Number: 1818910-2020-14996
• Device Sequence Number: 573994
• Product Code: NJL
• UDI-Device Identifier: 10603295052999
• UDI-Public: 10603295052999
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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 Model Number: 1516-50-906
• Device Catalogue Number: 151650906
• Device Lot Number: 8408074
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 9 CEM; ATTUNE RP TIB BASE SZ 8 CEM; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR