MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ1.5 L; KNEE FEMORAL COMPONENT

Catalog Number	196040150
Medical Device Problem Codes	Incorrect Device Or Component Shipped (2962); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/05/2017
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
It was reported that upon opening the box inside was a 2 left femur implant but supposed to be a 1.5 left femur implant (of pfc sigma).
Additional Manufacturer Narrative
product complaint # = > pc-000107742 investigation summary = > from the information reviewed, it was unlikely that a manufacturing or re-processing defect was present.The complaint shall be closed with an undetermined conclusion.It shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.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. .
Event or Problem Description
Complaint description: it was reported that upon opening the box inside was a 2 left femur implant but supposed to be a 1.5left femur implant (of pfc sigma)./ | investigation method: / | investigation summary:.

• Brand Name: SIGMA PS CEM FEM SZ1.5 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7000183
• Report Number: 1818910-2017-28021
• Device Sequence Number: 16395463
• Product Code: JWH
• UDI-Device Identifier: 10603295075011
• UDI-Public: 10603295075011
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 196040150
• Device Lot Number: C60385
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1