MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ2 RIGHT; PRSTHSIS,KNEE,PTLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/METAL/POLYMER

Catalog Number	71420180
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery a wrong implant was found.The right side size 2 tibial base plate was opened in the surgery for implanting and the scrub guy found out that the box contained anthem size 2 tibial base plate.The doctor implanted the same in the patient as there was no back up available.In genesis ii tibial implant box, anthem tibial implant was found with stickers.No delay was reported.Anthem and genesis sets were combined in the patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.A visual inspection of the photo attached shows chart stiks of implants but does not show 71420180/18jm05625.There are no photos of the actual packaging issue, product or the chart stik.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 prior complaints for the listed batch with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ2 RIGHT
• Common Device Name: PRSTHSIS,KNEE,PTLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8285709
• Report Number: 1020279-2019-00325
• Device Sequence Number: 14069223
• Product Code: JWH
• UDI-Device Identifier: 03596010206329
• UDI-Public: 03596010206329
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/08/2019

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: 71420180
• Device Lot Number: 18JM05625
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 06/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR