MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLYMER/METAL/POLY

Catalog Number	71453113
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, the doctor opened the packaging and found that the inner package had been unsealed.There was no altered product so the device was utilized by sterilized by isodine.As of today there is no harm to the patient like the infection.
Additional Manufacturer Narrative
The associated complaint device packaging was returned and evaluated.A visual inspection of the returned packaging indicated that one side of the inner pouch open along the side, confirming the stated complaint.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8176345
• Report Number: 1020279-2018-02829
• Device Sequence Number: 19164181
• Product Code: JWH
• UDI-Device Identifier: 00885556034538
• UDI-Public: 00885556034538
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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 Expiration Date: 02/26/2023
• Device Catalogue Number: 71453113
• Device Lot Number: 13BM17355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1