MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 9MM; PROST, KNEE, PATFEMTIB SEMI-CNSTRND, CMNTD, POLY/METAL/POLY

Model Number 71453221

Device Problem Material Rupture (1546)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal reference number: case (b)(4).

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2014, the patient experienced pain and instability since (b)(6) 2021.This adverse event led to a revision surgery performed on (b)(6) 2021 in which it was found a rupture of the posterior wedge of the lgn ps high flex xlpe sz 5-6 9mm.During the revision surgery, the lgn ps high flex xlpe sz 5-6 9mm wedge was explanted and intra-articular flushing was performed.The current health status of the patient is stable.

Manufacturer Narrative

Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The post ruptured from the device causing the adverse event.The remainder of the insert was not returned.The post shows signs of wear from prolonged use.The clinical/medical evaluation concluded that per complaint details, the patient underwent an arthroscopy procedure/revision approximately 7.5 years post implantation due to pain and instability.Reportedly, a rupture of the posterior wedge was noted intraoperatively; therefore, the wedge was explanted during the revision surgery followed by intra-articular flushing.It was communicated that the requested clinical documentation was not available.Without the requested medical documentation, the root cause of the reported event could not be fully assessed or concluded.The patient impact beyond the reported symptoms, intra-op findings, and revision procedure could not be determined.No further medical investigation could be rendered at this time.Any product evaluation will be performed independent of this medical investigation.Should a product evaluation conclusion result in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 5-6 9MM
• Type of Device: PROST, KNEE, PATFEMTIB SEMI-CNSTRND, CMNTD, POLY/METAL/POLY
• 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; 5123913905
• MDR Report Key: 12544927
• MDR Text Key: 273751789
• Report Number: 1020279-2021-07292
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556035337
• UDI-Public: 00885556035337
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 71453221
• Device Catalogue Number: 71453221
• Device Lot Number: 12JM17472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention