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

Model Number	1516-21-007
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Not Applicable (3189)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Received medical records on 05/30/2018.Records reviewed for mdr reportability.Left attune knee revised to address pain, persistent swelling, and gross flexion instability.Surgical diagnosis was failed left total knee, secondary to instability, malrotation, and tibial base plate loosening.Revising surgeon observed synovitis, malrotation of the tibial tray, gross loosening/debonding of the tibial tray at the cement to implant interface, and loosening of the femur component at the cement to bone interface (femur and cement came loose together with simple taps of the mallet).The patella, and the tibia cement mantle, were noted to be well-fixed.Tibial insert was described as pitted, but not delaminated.Patella was not revised; otherwise, all other depuy products replaced with competitor products.Doi: (b)(6) 2015; dor: (b)(6) 2017; (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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 10 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7625010
• Report Number: 1818910-2018-62823
• Device Sequence Number: 11333113
• Product Code: JWH
• UDI-Device Identifier: 10603295046264
• UDI-Public: 10603295046264
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2018

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: 08/31/2018
• Device Model Number: 1516-21-007
• Device Catalogue Number: 151621007
• Device Lot Number: 427515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 11/08/2019; 05/07/2020
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 12/12/2018; 11/13/2019; 05/08/2020
• 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: 71 YR