MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 71342800

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Sepsis (2067); Unequal Limb Length (4534)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a right hip bhr-tha revision surgery had been performed on (b)(6) 2020 following a metallosis and failed total hip arthroplasty diagnosis (case (b)(4)), the patient experienced a chronic and recalcitrant prosthetic joint infection.Despite multiple operations to address the infection in which an antibiotic spacer was placed, a resection arthroplasty was conducted on (b)(6) 2021 to further treat this adverse event.During this procedure, the acetabular liner and the femoral stem were explanted and a copious saline irrigation with excisional debridement on bony surfaces was performed.Intraoperatively, significant debris and apparent hematoma or infection was evident.Serial sequential washes were performed on the debrided surfaces, with a subsequent placement of stimulant beads including vancomycin and liquid tobramycin.The arthrotomy, fascia and skin were closed, until further evaluation of the clinical course of the patient was obtained to perform a definitive reconstruction.The patient¿s current health status is unknown (case (b)(4)).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the revision operative report confirms the reported infection.However, the clinical root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that the implants contributed to the infection.It cannot be concluded that the chronic infection is associated with a mal-performance of the implant.The patient impact beyond that which has already been reported cannot be determined.However it was noted that the patient is to have definitive reconstruction with femoral replacement.The surgeon planned for the patient to receive long-term antibiotics.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 instructions for use for this device revealed that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection have been identified in potential complications associated with total hip arthroplasty surgery.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.Possible causes could include but are not limited to contamination, 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.

Manufacturer Narrative

D11: concomitant medical products and therapy dates.Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the revision operative reports confirm the reported infection.However, the clinical root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that the implants contributed to the infection.It cannot be concluded that the chronic infection is associated with a mal performance of the implant.The patient impact is the chronic infection and multiple right hip surgeries.Last notation indicated he ambulates with a walker and awaits another revision arthroplasty.No further clinical assessment is warranted at this time.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 revealed similar events for the listed devices over the previous 29 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 in potential complications associated with total hip arthroplasty surgery.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 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.H6: health effect - clinical code, health effect - impact code, investigation conclusions and investigation findings.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 14570612
• MDR Text Key: 293136813
• Report Number: 1020279-2022-02717
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474148
• UDI-Public: 03596010474148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 71342800
• Device Catalogue Number: 71342800
• Device Lot Number: 19KM23056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 06/24/2022; 04/24/2024
• Supplement Dates FDA Received: 06/28/2022; 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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
• Treatment: ACETABULAR CUP HAP SIZE 52/58, LOT#:08FW17572
• Patient Outcome(s): Other; Required Intervention