MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after tka surgery was performed 13 years ago, the patient knew felt the knee was becoming less and less stable until it became completely unstable.A revision surgery was performed on (b)(6) 2024 and it was noticed that the post on one (1) lgn ps high flex xlpe sz 7-8 11mm snapped off and it was in two pieces insitu.This adverse event was solved by removing and replacing the device.After day 10 post-op, patient is recovering well.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that the post is fractured off.This piece was returned.The device also reveals discoloration, scratches and gouges.This inspection was conducted by naked eye.The clinical/medical investigation concluded that the photos provided confirm the post fractured from the insert.The instructions for use for the knee systems does warn that the implant can break or become damaged as a result of strenuous activity or trauma.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided, the broken post is likely a contributing factor to the reported instability that led to the revision.However, there were no clinical factors found which would have contributed to the breakage of the insert¿s post.It is unknown if the instructions for use for the knee systems was adhered to.The patient impact beyond the reported revision could not be determined since the patient is still recovering.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Based on the conclusions of the product history review and the device evaluation, further product evaluation is not required because there is no evidence that a manufacturing deficiency occurred.A review of complaint history revealed similar events for the listed device over 12 months, however, no commonalities that would suggest a device deficiency was found nor an adverse trend.This failure mode will be monitored for future complaints for any necessary corrective actions.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.According with the material specification, the quality and manufacture of 7.5 mrad cross-linked ultra-high-molecular-weight polyethylene (uhmwpe) bar stock shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 11MM
• 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: 18927235
• Report Number: 1020279-2024-00564
• Device Sequence Number: 9291504
• Product Code: JWH
• UDI-Device Identifier: 00885556035153
• UDI-Public: 00885556035153
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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 Catalogue Number: 71453232
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown