MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	08/27/2018
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
The patient underwent a revision of the left knee secondary to pain, decreased range of motion and suspected tibial loosening.Intraoperatively, the surgeon discovered tibial loosening at the cement to implant interface and medial tibial osteolysis.The femoral and patellar components were well-fixed.No intraoperative complications were noted.Doi: (b)(6) 2016.Dor: (b)(6) 2018, left knee.
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.H6 patient code: no code available (3191) used to capture the surgical intervention and medical device removal.

• Brand Name: ATTUNE CR RP INSRT SZ 6 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9548146
• Report Number: 1818910-2020-00490
• Device Sequence Number: 19435164
• Product Code: NJL
• UDI-Device Identifier: 10603295047896
• UDI-Public: 10603295047896
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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 Expiration Date: 01/31/2018
• Device Model Number: 1516-30-608
• Device Catalogue Number: 151630608
• Device Lot Number: 3572202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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 CR FEM LT SZ 6 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR