MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 5 LT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED

Model Number	71424005
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tibia was revised for loosening.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The root cause of the revision was reportedly loosening.The patient impact beyond the reported loosening and subsequent revision could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The root cause of the revision was reportedly loosening.The patient impact beyond the reported loosening and subsequent revision could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include poor bone quality or improper sizing.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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 REV TIBIA BASE SZ 5 LT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9109531
• Report Number: 1020279-2019-03459
• Device Sequence Number: 19643920
• Product Code: JWH
• UDI-Device Identifier: 03596010546098
• UDI-Public: 03596010546098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

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 Model Number: 71424005
• Device Catalogue Number: 71424005
• Device Lot Number: 33CM10280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 02/21/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/04/2019; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PS FLEX XLPE SZ 5-6 15MM 71453224/14BT39694.; STEM 14MM X 160MM 71424047/14EAB00010.; PS FLEX XLPE SZ 5-6 15MM 71453224/14BT39694; STEM 14MM X 160MM 71424047/14EAB00010
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR