MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 10MM X 120MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number 71424023

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526)

Event Date 03/12/2021

Event Type  Injury  

Event Description

It was reported that, after a right tkr surgery in 2019, plaintiff continued to experience significant and excruciating pain in the right knee.Plaintiff was diagnosed with a metal allergy to cobalt, chromium, and nickel.Plaintiff underwent revision surgery on (b)(6) 2021 to replace the implants with ones that did not contain metals.(case-(b)(4)) during revision surgery, once the surgeon cemented the replacement implants it was known that the new implants also contained cobalt and chromium therefore the surgeon had to chisel away the cement and remove the new implants (case-(b)(4)) this second procedure resulted in bone fracture in the right leg, causing pain and severe post-surgical discomfort.Plaintiff has had to undergo additional rehabilitation treatment and suffers from permanent instability and restricted mobility.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

*us legal* it was reported that, after a right tkr surgery in 2019, plaintiff continued to experience significant and excruciating pain in the right knee.Plaintiff was diagnosed with a metal allergy to cobalt, chromium, and nickel.Plaintiff underwent revision surgery on (b)(6) 2021 to replace the implants with ones that did not contain metals.(b)(4) during revision surgery, once the surgeon cemented the replacement implants it was known that the new implants also contained cobalt and chromium therefore the surgeon had to chisel away the cement and remove the new implants (b)(4) this second procedure resulted in bone fracture in the right leg, causing pain and severe post-surgical discomfort.Plaintiff has had to undergo additional rehabilitation treatment and suffers from permanent instability and restricted mobility.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, after the revision implants were cemented, it was (made) known that the new implants also contained metals to which the patient was allergic and required a second intra-operative procedure (explant allergenic components/2nd revision) during which a right leg bone fracture occurred, causing pain and severe post-surgical discomfort.Reportedly, the patient had to undergo additional rehabilitation treatment and allegedly suffers from permanent instability and restricted mobility.No supporting documentation has been provided as of the date of this medical investigation.Without the requested documentation/information, the root cause of the reported events could not be further assessed.The patient impact beyond that which was reported cannot be determined.No further medical assessment can be rendered at this time.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 some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

Manufacturer Narrative

Section d4 was corrected.

Event Description

It was reported that, after a right tkr surgery on (b)(6) 2019, plaintiff continued to experience severe, excruciating pain in the right knee.On (b)(6) 2020, plaintiff was diagnosed with a metal allergy to cobalt, chromium, and nickel.Plaintiff underwent revision surgery on (b)(6) 2021, to replace the implants with ones that did not contain metals.During revision surgery, after the surgeon had cemented the knee replacement implants, it was known that the tibial stem contained cobalt/chromium containing nickel.The implant was unimpacted.The cement was removed from the tibial canal and the tibial stem was removed off this component and a titanium stem 10x120mm was impacted.Case-(b)(4) this second procedure resulted in a bone fracture in the right leg, causing severe post-surgical pain and discomfort.Plaintiff has had to undergo additional rehabilitation treatment and has been treated conservatively, it is unknown if she has had additional revision surgery.Case (b)(4).

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the fracture that resulted from the removal of the first revision implants could be contributed to human error in providing components with the same material make-up, and once again not a mal performance of the implants.No further clinical/medical assessment is warranted at the time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that a list of indications, contraindications, and adverse effects, and states that considerations of anatomic loading, soft-tissue condition, and component placement are critical to minimize a variety of postoperative complications.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error, post-operative patient condition and/or surgical technique.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

• Brand Name: LGN PRESSFIT STEM 10MM X 120MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: 14192079
• MDR Text Key: 289952774
• Report Number: 1020279-2022-01934
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010546630
• UDI-Public: 03596010546630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: 71424023
• Device Catalogue Number: 71424023
• Device Lot Number: 11HAB0004A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization