MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 14MM X 160MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71424047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a right knee replacement surgery had been performed on (b)(6) 2017, the patient was fine except that there was pain in the tibia, at the end of the stem, caused by stress forces.At the 1.5 year mark it was determined that the stem was causing a compression fracture.Pins and plates were put in, but pain remained.Now, two (2) years later, the patient has again a compression fracture going up from the stem into the prosthesis, which limits mobility.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a patient with a complex knee history experienced persistent pain post-right tka with ¿the stem causing a compression fracture¿ at 1.5 years with limited mobility (implanted may 31,2017).Reportedly, the surgeon indicated the ¿pain was from the stress of the stem¿was common, could happen with any stem¿.Although it was communicated that the patient had (competitor) pins/plating/¿internal fixation to take the stress off the tibia from stem¿, the results from the reported plating and requested documentation had not been provided for inclusion in the medical investigation as of the date of this assessment.Without the requested documentation, the clinical root cause of the reported event could not be definitively concluded.The patient status beyond the reported limited mobility and ¿compression fracture going up from the stem into the prosthesis¿ could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.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 PRESSFIT STEM 14MM X 160MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12668088
• Report Number: 1020279-2021-07636
• Device Sequence Number: 14575270
• Product Code: JWH
• UDI-Device Identifier: 03596010546791
• UDI-Public: 03596010546791
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71424047
• Device Catalogue Number: 71424047
• Device Lot Number: 17AAB0026A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female