MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71434409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the ball bearings that hold the valves collett in place came loose.Device broke in patient, all pieces accounted for.No delay or injury reported.No back up required, device use had been completed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Both ball plungers disassembled from the device and only one was returned with the device.The device was manufactured in 2017 and exhibits signs of moderate wear/usage.A dimensional inspection was performed and an out of tolerance feature was found that could have contributed to the failure.Corrective action is being addressed by the internal quality hold process.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN AP FEM CUTTING BLK SZ 4
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8201038
• Report Number: 1020279-2018-02929
• Device Sequence Number: 2154577
• Product Code: HRY
• UDI-Device Identifier: 03596010549174
• UDI-Public: 03596010549174
• Combination Product (Y/N): N
• PMA/510(K) Number: K121393
• 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): 04/01/2019

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: 71434409
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1