MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

Device Problem Noise, Audible (3273)

Patient Problems Discomfort (2330); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a tkr surgery, the patient indicated that his knee replacement is noisy and rattles, with swelling for over 2 years.A revision surgery was performed on an unspecified date to solve this issue.The current health status of the patient is unknown.

Manufacturer Narrative

H2: additional information ¿h6¿.H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the knee replacement is noisy and rattles, with swelling for over 2 years.The patient reported in the complaint email that the problem occurred (b)(6) 2021 and indicated knee replacement has been replaced twice.As of the date of this medical investigation, the requested information has not been provided; therefore, no contributing clinical factors were identified and the current health status of the patient is unknown.The patient impact beyond the reported ongoing knee symptoms over 2 years cannot be determined as it is unknown if the reported knee replacement was performed for this particular adverse event.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.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: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• 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: 18833443
• MDR Text Key: 336853546
• Report Number: 1020279-2024-00487
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention