MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-203
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scarring (2061); No Code Available (3191)
Date of Event	11/26/2018
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
The patient underwent a right knee revision due to pain and nickel allergy.The tibial tray was subsided, malpositioned, and loose at the cement to implant interface.The femoral component was malpositioned and loose at the cement to implant interface.The surgeon noted scarring and synovitis.The surgeon reported erosive cystic change on both the femur and tibia.Depuy cement was used during the primary operation.Doi: (b)(6) 2014, dor: (b)(6) 2018, right knee.
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 = > the device associated with the reported event was not returned to the investigation site for evaluation.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 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.Product complaint (b)(4).Investigation summary : the device associated with the reported event was not returned to the investigation site for evaluation.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 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: the device associated with the reported event was not returned to the investigation site for evaluation.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 will be filed as appropriate.

• Brand Name: ATTUNE PS FEM RT SZ 3 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8927954
• Report Number: 1818910-2019-102112
• Device Sequence Number: 254007
• Product Code: JWH
• UDI-Device Identifier: 10603295041740
• UDI-Public: 10603295041740
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup,Followup
• Report Date (Section B): 08/02/2019

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: 1504-10-203
• Device Catalogue Number: 150410203
• Device Lot Number: 459972
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/26/2019; 03/12/2020; 03/12/2020
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/26/2019; 03/12/2020; 03/15/2020
• 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 PS FB INSRT SZ 3 7MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR