MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMPSZ 6 RIGHT; PRSTHSIS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR

Catalog Number	71420026
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that box states 6 right, actual size inside box 4 left.
Additional Manufacturer Narrative
The associated device and packaging was returned and evaluated.A visual examination of the packaging indicated that the incorrect size implant was packaged.A quality hold was placed in an attempt to quarantine and re-inspect additional product for this failure mode.This issue has also been communicated to our management process for their consideration of further action.It has been elevated to our risk assessment process to determine if any additional actions are needed.On (b)(6) 2018, smith & nephew initiated a voluntarily initiated a recall to remove two lots of genesis ii non porous c/r femoral due to a manufacturing packaging error.The affected devices were packaged and labeled as genesis ii non porous c/r femoral size 6 right; the package actually contained a genesis ii non porous c/r femoral size 4 left.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints.Credit cannot be issued for the device.

• Brand Name: GEN II COCR CR NP FEMORAL COMPSZ 6 RIGHT
• Common Device Name: PRSTHSIS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7753502
• Report Number: 1020279-2018-01471
• Device Sequence Number: 1719817
• Product Code: JWH
• UDI-Device Identifier: 03596010205568
• UDI-Public: 03596010205568
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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 Expiration Date: 07/01/2024
• Device Catalogue Number: 71420026
• Device Lot Number: 16CMB0061A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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: Other