MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number 71453221

Device Problems Fracture (1260); Device Damaged Prior to Use (2284); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during set up and inspection, a lgn ps high flex xlpe sz 5-6 9mm was found with a visible manufacturing error.On the picture provided it appears to be a fracture on one side of the device.As this was noticed during set up or inspection, the patient was not yet involved.

Event Description

It was reported that, during a knee replacement surgery, a lgn ps high flex xlpe sz 5-6 9mm was found with a visible manufacturing error with a missing plastic bit.It seems like it is a kind of manufacturing error during molding process.Procedure was resumed, without any delay, by using a spare implant.There was not any consequence for the patient.

Manufacturer Narrative

B5, d9, e1.

Manufacturer Narrative

Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that device does not reveal the stated failure mode.The returned device has damage along the base, more than likely from attempted insertion.Based on the evidence provided, the unsatisfactory experience could be confirmed.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 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 to the inspection drawing, the visual inspection includes verifying parts are free of burrs, pitts, sharp edges, nicks, scratches and damage areas, besides, it should be verified surface finish of part is uniform.The product was returned to s+n by the customer.The described damage could be confirmed.However, the affected product shows further considerable signs of use, indicating that an attempt was made to insert the product into a base plate.Based on the results of the investigation, no manufacturing related issue could be identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.A factor that could contribute to the reported event include insertion 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 for future complaints and investigate as necessary.We consider this investigation closed.H6: health effect - impact code and medical device problem code.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 9MM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 15535501
• MDR Text Key: 305932809
• Report Number: 1020279-2022-04289
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556035337
• UDI-Public: 00885556035337
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71453221
• Device Catalogue Number: 71453221
• Device Lot Number: 22CT61265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1