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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a left tka had been performed on (b)(6) 2022 with an unspecified system that contains an oxinium femoral component, the patient started experiencing significant swelling and fluid on the knee.The patient has gone to the hospital twice to have fluid drained from his knee.The patient is concerned about implant rejection.The patient also indicates that none of these issues happened with contralateral previous knee replacement that had been performed on 2019.Revision surgery has not been indicated yet; however, the patient is currently unable to walk, the swelling persists, and he continues experiencing pain.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the patient is experiencing persistent pain and significant swelling/fluid on the knee and is ¿unable to walk¿ approximately 9 months post tka with and unknown oxinium femoral component.Reportedly, the patient has gone to the hospital twice ¿to have fluid drained from his knee¿; however, a ¿revision (is) not indicated yet¿.Of note, the patient indicated ¿none of these issues¿ happened with contralateral tka in 2019.The requested medical documentation has not been received as of the date of this medical investigation.Correspondence reveals that medical records/operative notes are not available and the doctor/hospital ¿will not¿ accept patient calls or provide further information¿.The reported current health status ongoing symptoms/adverse event has not been resolved yet.Without the requested clinical documentation, possible contributing clinical factors could not be definitively concluded, and the source of the reported persistent pain with significant swelling/fluid on the knee and inability to walk cannot be determined.The patient impact beyond the reported symptoms and aspirations performed at the hospital cannot be determined; however ¿revision surgery has not been indicated yet¿.No further medical assessment could be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, post-operative healing issue, patient condition and/ or postoperative care.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 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: UNKNOWN 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: 15956505
• MDR Text Key: 305241980
• Report Number: 1020279-2022-04932
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male