MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71336450

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Osteomyelitis (4533)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).

Event Description

It was reported that, approximately 4-5 years after a tha revision surgery was performed on the patient¿s left hip on (b)(6) 2018 due to mechanical failure of the femoral component, the patient experienced a chronic infected left tha with a draining sinus from the distal aspect of the incision with purulent material surrounding the entire prosthesis, all associated to a growing gamma hemolytic streptococcus sp.A revision surgery with extensive irrigation and debridement was performed on (b)(6) 2022 to treat this adverse event.During this procedure, both the femoral and acetabular components were removed and replaced with a new tha prosthesis.Intraoperatively, there was bone loss involving the lateral aspect of the femoral diaphysis in the junction of the proximal and central third of the femur and erosion of the cortical shaft of the femur was found due to the ongoing infection.The procedure was successfully completed without any complications.

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, as this infection developed about four years after the first revision, it is likely that the there is a hematogenous source.Also the components used are not smith and nephew products.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection have been identified as potential complications associated with total hip arthroplasty surgery, primary or revision.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.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 loss of sterility during procedure, patient reaction, and post-operative healing issue.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.

• Brand Name: REF THREE HOLE SHELL 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 15577888
• MDR Text Key: 301501295
• Report Number: 1020279-2022-04388
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454348
• UDI-Public: 03596010454348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71336450
• Device Catalogue Number: 71336450
• Device Lot Number: 15AM01919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male