MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71342340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Medical device site infection (4845)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Initial reference number:(b)(4).
Event or Problem Description
It was reported that, after a primary thr performed on (b)(6) 2023, the patient presented with a suspected infection of the hip replacement.They required to come back to theatre for a wound and joint wash out and head exchange.Patient's outcome is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-rays were reviewed but do not aid in determining a clinical root cause of the reported infection, as the infection cannot be viewed on the images.However, the one of the undated x-ray images does appear to show a void in the femoral cortex around the stem which could indicate fracture or a remaining void from a previous procedure (such as cerclage cable or cortical screw).The reported infection is highly likely of an exogenous nature, and it cannot be concluded the reported infection was associated with the implant.The patient impact is the reported infection and subsequent incision and drainage and revision.A review of the production orders 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 risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and event.A review of the instructions for use documents for total hip systems revealed infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection has been identified in potential complications associated with total hip arthroplasty surgery, primary or revision section.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.
Event or Problem Description
It was reported that, after a primary thr performed on (b)(6) 2023, a revision had to be carried out on (b)(6) 2023 due to infection of the hip replacement.The infection included the deep tissues and debridement and washout of all layers was performed.The primary femoral head and taper sleeve were explanted.Further debridement of tissue within the hip joint and around the femoral stem was also undertaken.Patient's current health status is unknown.

• Brand Name: 40MM OXINIUM MODULAR HEAD
• Common Device Name: 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: 18436496
• Report Number: 1020279-2024-00010
• Device Sequence Number: 20588978
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/03/2026
• Device Catalogue Number: 71342340
• Device Lot Number: 16KM02664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71344245 / LOT NUMBER: 18AT98135.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown