MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF V POR ACET SHELL 60OD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 740060

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

Patient Problem Solid Tumour (4552)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).(b)(6).

Event Description

It was reported that, after thr revision surgery had been performed on 2013, the patient has experienced a pseudotumor about the medial aspect of the acetabulum.This adverse event will be solved by a second revision surgery.Current health status of patient is unknown.

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, although pseudo tumors may be associated with metallic wear debris, and or metallosis, without the requested clinical information, the root cause of the reported pseudo tumor cannot be fully assessed or definitively concluded.The details of the 2013 liner revision and possible contribution to the reported events are also unknown.Therefore, further patient impact beyond the reported pseudo tumor and planned second revision could not be assessed or determined.No further medical assessment could be rendered at this time.A review of complaint history did not reveal similar events for the listed device.A historical review concluded that there are no prior actions related to this product and event.The contribution of the device to the reported event could not be corroborated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness, lifetime of device, damaged product, implant corrosion or wear.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.

• Brand Name: REF V POR ACET SHELL 60OD
• 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: 12708917
• MDR Text Key: 278760656
• Report Number: 1020279-2021-07701
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010259646
• UDI-Public: 3596010259646
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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 Catalogue Number: 740060
• Device Lot Number: 60604823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 01/24/2022
• 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): Hospitalization; Other