MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMPSZ 3 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420116
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when they opened the box of the mentioned reference, a left implant was expected but inside a right implant was found.The implant was used and we realized once surgery was completed.No delay was reported and a revision surgery was performed due to this incident.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned gii np femoral component indicated surface damage and the presence of cement in the lug holes, suggesting attempted use.The returned femoral was a different batch then originally reported and was a right hand device.A clinical analysis indicated that based on the limited information provided, human elements from packaging, labeling, and implantation cannot be ruled out as contributing factors of the reported implantation of an incorrect-sided component.The patient impact beyond the revision procedure (including an increased risk for infection) and the expected post-op recovery cannot be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no other complaint for the listed batch.Based on this investigation, the need for corrective action is not indicated.No further investigation is 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 PS NP FEMORAL COMPSZ 3 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8460594
• Report Number: 1020279-2019-01238
• Device Sequence Number: 3014009
• Product Code: JWH
• UDI-Device Identifier: 03596010206022
• UDI-Public: 03596010206022
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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 Catalogue Number: 71420116
• Device Lot Number: 17JM08310
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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: Hospitalization; Required Intervention