MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMPSZ 6 RIGHT; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420026
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on (b)(6) 2018, total knee replacement procedure was performed with the genesis ii system.During the procedure, standard cutting and sizing techniques were used.At the stage of sizing of the components femoral components size 6 right side, right tibia size 4 and the insert cr 3-4 9 mm were selected.The component assembly stage was completed with the selection of the correct components and confirmation of their parameters by the scrub nurse and the main operator.After opening the packaging marked ref: 71420026 and batch no 16cmb0066a, cementation implants were prepared.At the components cementing stage, it was found that the femoral components is size 4 and the left side (ref 71420006 batch 14cm08606) not as shown in the packaging and labels.The tibia itself was cemented but femoral components had to be opened with the new right one in which the implant was properly packed.
Additional Manufacturer Narrative
The associated genesis ii non-porous cruciate retaining femoral component was returned and evaluated.A visual inspection of the product confirms the stated failure.The device in the package does not match the part and lot number on the packaging label.Our investigation indicated that the related device was part of field action initiated in 2018.Corrective actions have been initiated.Our clinical evaluation noted that no adverse outcome to the patient has been reported as a result of the extended surgery.The procedure was completed with a back-up.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GEN II COCR CR NP FEMORAL COMPSZ 6 RIGHT
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7697381
• Report Number: 1020279-2018-01312
• Device Sequence Number: 11025523
• Product Code: JWH
• UDI-Device Identifier: 03596010205568
• UDI-Public: 03596010205568
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/01/2018

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: 03/01/2024
• Device Catalogue Number: 71420026
• Device Lot Number: 16CMB0066A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 11/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization