MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POS FEM WDG 5MM SZ7-8 LNG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71421807

Device Problem Positioning Problem (3009)

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

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Our reference number: (b)(4).

Event Description

It was reported that, during the set up for a tka procedure, when the surgeon was screwing a size 7-8 5mm posterior femoral wedge on the medial side of a size 7 legion constrained femoral component the wedge would not seat.Surgeon used another screw for a 5mm posterior femoral wedge and it still did not seat.The surgeon tried the wedge on the lateral side and it did seat.Procedure was finished with the same device, but the surgeon did not use the wedge as planned for the medial side and implanted the femoral component without it.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN POS FEM WDG 5MM SZ7-8 LNG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11366398
• MDR Text Key: 233094227
• Report Number: 1020279-2021-01537
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010545411
• UDI-Public: 03596010545411
• Combination Product (y/n): N
• PMA/PMN Number: K052792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 71421807
• Device Catalogue Number: 71421807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention