MAUDE Adverse Event Report: JOINT RECON : DEPUY IRELAND ATTUNE CR FEM RT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400209
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot: null.Device history review: null.
Event or Problem Description
Der states that patient's knee may not have been properly aligned during his primary knee replacement procedure.
Additional Manufacturer Narrative
(b)(4).Investigation summary:the received device was forwarded to commercialized product development for evaluation.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FEM RT SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): JOINT RECON : DEPUY IRELAND
• MDR Report Key: 7179785
• Report Number: 1818910-2018-50836
• Device Sequence Number: 19099445
• Product Code: JWH
• UDI-Device Identifier: 10603295041245
• UDI-Public: 10603295041245
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150400209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR