MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REFLECTION LINER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problems Degraded (1153); Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Date 09/27/2019

Event Type  Injury  

Event Description

It was reported that on literature review "(b)(6) infection of total hip arthroplasty after intravesicular bacillus calmette-guerin", after a left tha performed on 2005, the patient had a fluctuant subcutaneous collection over the anterior aspect of the left thigh.The radiography revealed eccentric wear of polythene liner and proximal femoral osteolysis.A magnetic resonance imaging scan showed a lesion overlying the quadriceps.The patient underwent revision surgery with exchange of the liner and the head on (b)(6) 2015.It is unknown if the devices implanted during revision were from smith and nephew.Patient is recovered.No further information is available.

Manufacturer Narrative

(b)(4).Williams, a., arnold, b., & gwynne-jones, d.P.(2019).Mycobacterium bovis infection of total hip arthroplasty after intravesicular bacillus calmette-guérin.Arthroplasty today, 5(4), 416-420.Doi: doi.Org/10.1016/j.Artd.2019.08.004.

Manufacturer Narrative

H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to inflammation, surgical complication, traumatic injury, adverse reaction, patient condition, friction, joint tightness or lifetime of device.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).

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to inflammation, surgical complication, traumatic injury, adverse reaction, patient condition, friction, joint tightness or lifetime of device.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.

Manufacturer Narrative

H6: medical device problem code.

• Brand Name: UNKN REFLECTION LINER
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 13863987
• MDR Text Key: 288808589
• Report Number: 1020279-2022-01276
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• 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): Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male