MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POS FEM WDG 10MM SZ5-6 LNG; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71421806

Device Problem Nonstandard Device (1420)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal reference: (b)(4).

Event Description

It was reported that, during a tka revision surgery, two (2) lgn pos fem wdg 10mm sz5-6 lng were opened but the screws were too short to be used.The procedure was resumed, after a significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photograph was reviewed, and revealed that the image provided of the box shows the label with the correct device identifiers, in addition the box has been opened.However, through this inspection the stated allegation can not be confirmed since there is only a picture of the box.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 with inspection procedure, the final inspection includes the verification of part configuration per print.Also, the screws should be measured with a caliper to ensure the correct size.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.A factor that could contribute to the reported event include size selected.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: LGN POS FEM WDG 10MM SZ5-6 LNG
• Type of Device: 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: 18925383
• MDR Text Key: 337926295
• Report Number: 1020279-2024-00551
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010545404
• UDI-Public: 03596010545404
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K041106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71421806
• Device Lot Number: 21ESM0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1