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

Model Number	71453232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr, patient suffered some trauma on the knee treated.Revision surgery was performed on march 4th, after verifying by arthroscopy that the ps post had snapped.Broken legion ps high flex xlpe size 7-8 11mm was replaced with a 7-8 13mm poly.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the as received component was visually inspected for signs of damage.The tibial insert showed signs of wear related to damage to the articulating surface.The post was fractured near the base of the post.Signs of deformation were observed on the base region of the insert¿s post.No material or manufacturing defects were observed during this investigation.The clinical/medical evaluation concluded that this case reports that the patient suffered knee trauma after a tkr.An arthroscopy was performed and found the insert post had broken.The patient underwent a revision/poly exchange.Per email correspondence, the requested surgical records and x-rays will not be provided, as no consent has been granted to release this information.Without sufficient supporting medical evidence, the reported event cannot be thoroughly assessed, and a medical assessment cannot be rendered.Should medical/clinical records be provided, the clinical task can be re-evaluated and assessed at that time.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.At this time, we do not have 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 and potential harm was previously identified.Some potential probable causes for this event could include but not limited to a traumatic injury or surgical technique.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 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: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11587184
• Report Number: 1020279-2021-02471
• Device Sequence Number: 4182320
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2025
• Device Model Number: 71453232
• Device Catalogue Number: 71453232
• Device Lot Number: 15KT59992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention