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	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total knee replacement, after opening the packaging marked as femoral component size 6 right side it was found that the femoral components is size 4 and the left side not as shown in the packaging and labels.The tibia itself was cemented, unfortunately another femoral component was not available in the second line of consignment (no replenishment), re-sizing and re-cutting of posterior/ anterior/chamfers was done and the smaller size was implanted, (right "5") but a indentation in the cochlea should be noted which may result in weakening of the structure femur and affect the increased risk of fracture of femur.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.However, our investigation indicated that the related failure was part of field action initiated in 2018.Corrective actions have been initiated.Our clinical evaluation noted that no clinical relevant information has been provided to conduct a thorough clinical investigation.The impact to the patient beyond the surgeon's statement cannot be concluded.No further clinical/medical assessment is warranted at this time.Should additional information is received in the future, this 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: 7705810
• Report Number: 1020279-2018-01284
• Device Sequence Number: 732558
• 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): 07/19/2018

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
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other