MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 10 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-010
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); No Code Available (3191)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Additional 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.Occupation is a non-healthcare professional.(b)(4).
Event or Problem Description
On (b)(6) 2016, the patient underwent a right knee revision due to loosening of the tibial component, and pain.The surgeon reported the tibial component was loose with fragmented cement and synovitis.He noted the femoral and patellar components were solid and not revised.The patient was implanted with depuy tibial revision system and depuy cement x 1.There were no complications reported with the procedure.Doi: (b)(6) 2014; doi: (b)(6) 2016; (rt 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.E3 initial reporter occupation: lawyer.Patient code: no code available (3191) was used to capture medical device removal.

• Brand Name: ATTUNE FB TIB BASE SZ 10 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9409734
• Report Number: 1818910-2019-120087
• Device Sequence Number: 4202713
• Product Code: JWH
• UDI-Device Identifier: 10603295042440
• UDI-Public: 10603295042440
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1506-00-010
• Device Catalogue Number: 150600010
• Device Lot Number: 6547036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 08/26/2020
• 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 MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 10 5MM; ATTUNE PS FEM RT SZ 10 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR