MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640710
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); No Code Available (3191)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Medical records received 17 june 2019 and were reviewed 12 september 2019 for mdr reportability.On (b)(6) 2014, the patient underwent total right knee arthroplasty due to osteoarthritis.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications and patient was transferred to recovery in satisfactory condition.The patient was implanted with the attune knee system and depuy bone cement x 2.On (b)(6) 2018, the patient underwent a right knee revision due to loosening of the tibial component, and pain.The surgeon indicated there was synovitis consistent with polyethylene wear and loosening.He noted the femur was not loose, though revised.The tibial component was loose and there was no cement adherence at the cement/bone interface nor the cement / implant interface.It was noted the patella tracked well and no releases were necessary.The patella was not revised.The surgeon reported tissue specimen came back as having chronic inflammation but no evidence of acute inflammation or bacteria.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2014.Dor: (b)(6) 2018, (rt knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 7 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9153014
• Report Number: 1818910-2019-107629
• Device Sequence Number: 14205208
• Product Code: JWH
• UDI-Device Identifier: 10603295050247
• UDI-Public: 10603295050247
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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 Expiration Date: 01/30/2019
• Device Catalogue Number: 151640710
• Device Lot Number: 481956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR