MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a tkr surgery performed on (b)(6) 2017, in (b)(6) 2024, the patient reported an acute onset of instability while he was on his knees in deep flexion in a roof cavity conducting a building inspection.The surgeon examined the patient and the instability was noted, suspected failure of ps post.A revision surgery was booked to investigate same and surgery was performed on (b)(6) 2024.When the knee was opened to inspect the implant, it was found that the post had completely broken off the lgn ps high flex xlpe sz 5-6 11mm.The insert was replaced with another product of the same reference number.The patient was compliant with post-operative instructions.Specimens were taken to examine if poly traces can be found in the surrounding tissue.The current health status of the patient is good.
Additional Manufacturer Narrative
Additional information: d4 (lot number and expiration date), d9, h4.
Additional Manufacturer Narrative
H6: type of investigation h3,h6: the associated device was returned and evaluated.The visual inspection revealed the post fractured off.The piece was returned.The visual also reveals discoloration, scratches and gouges.The explant shows signs of significant wear and use.This inspection was conducted by naked eye.The knee insert post 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.The clinical/medical investigation concluded that, undated photos of the implant were provided for review and confirm the reported breakage, however the photos do not indicate a root cause for the breakage.Based on the information provided the clinical root cause of the reported instability was the noted insert breakage.The cause for the breakage could not be determined based on the limited information provided.It cannot be concluded that the reported event is related to a malperformance of the implant.The patient impact is determined to be the revision, and a brief post-operative recovery phase would be anticipated.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.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 bar stock shall be controled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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 5-6 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: 20190512
• Report Number: 1020279-2024-01803
• Device Sequence Number: 15516473
• Product Code: JWH
• UDI-Device Identifier: 00885556035351
• UDI-Public: 885556035351
• 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 Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 10/29/2024

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 Expiration Date: 02/23/2026
• Device Catalogue Number: 71453222
• Device Lot Number: 16BT65527
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/24/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/17/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 104 KG