MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAINED,CEMENTED,METALPOLYMER

Model Number 71421377

Device Problems Difficult to Insert (1316); Defective Component (2292)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, the lgn hk fem assembly sz 7 lt would not allow the legion hk sleeve to be inserted into them.However, they managed to pass the sleeve through the link assembly by lightly impacting it.Surgery was resumed, with a delay of greater than 30 minutes, with the same device.Patient was not harmed.No further complications reported.

Manufacturer Narrative

H10: this event was evaluated by our quality team, however, since the device was not returned to smith and nephew and it was implanted, the reported failure mode cannot be confirmed.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An historical review concluded that there are no prior actions related to this product and event.According to the inspection drawing, final inspection includes verifying parts are free of burrs, pits, sharp edges, nicks or damage areas.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Internal complaint reference number: (b)(4).

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The picture provided was reviewed by the internal quality team and could not confirm the defective condition.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According to the inspection drawing, final inspection includes verifying parts are free of burrs, pits, sharp edges, nicks or damage areas.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.At this time, we have no evidence to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Internal complaint reference number: (b)(4).

• Brand Name: LGN HK FEM ASSEMBLY SZ 7 LT
• Type of Device: PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAINED,CEMENTED,METALPOLYMER
• 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: 14292306
• MDR Text Key: 290948354
• Report Number: 1020279-2022-02202
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556414880
• UDI-Public: 00885556414880
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 71421377
• Device Catalogue Number: 71421377
• Device Lot Number: 16MM04280
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1