MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; KNEE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number UNKNOWN

Device Problems Material Deformation (2976); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Failure of Implant (1924)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, following a tka revision conducted on (b)(6) 2018 on the patient¿s left knee, the patient sustained recurrent bleeding episodes, hematoma formation around the left knee and the loosening and deformation of the prosthesis, which made necessary a second revision surgery during the spring of 2019.The identity of the explanted devices and the prosthesis implanted in exchange remains unknown.The patient continues to experience pain while walking and standing.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a second left total knee arthroplasty revision was performed within approximately 6 to 8 months post first revision due to recurrent bleeding episodes, hematoma formation around the left knee and the loosening and deformation of the prosthesis.Reportedly, the patient continues to experience pain while walking and standing.As of the date of this medical investigation, the supporting clinical documentation has not been provided; therefore, no definitive clinical factors could be assessed which would have contributed to the event.With the limited information provided, the patient impact beyond the reported events and subsequent second revision cannot be determined; however, a malperformance of any component cannot be confirmed.No further medical assessment can be rendered at this time.Should clinically relevant documentation become available, the clinical/medical task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, osteolysis, surgical technique used, traumatic injury, patient reaction, post-operative healing issue and/or patient condition.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: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: KNEE ARTHROPLASTY IMPLANTATION SYSTEM
• 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: 15318286
• MDR Text Key: 298868191
• Report Number: 1020279-2022-03873
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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