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

Model Number 71342800

Device Problem Biocompatibility (2886)

Patient Problem Seroma (2069)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a revision was performed on the (b)(6) 2022, the patient developed a seroma on the left hip for which he entered the surgical room on the (b)(6)2022, for an irrigation and debridement procedure.After this procedure, the patient continued to have persistent wound drainage and it was decided to perform an additional revision surgery on the (b)(6) 2022, on which the femoral head and liner were explanted and exchange with new identical devices.The patient was then transferred to the hospital bed and taken to the recovery room stable condition.

Manufacturer Narrative

H6: health effect - clinical code and health effect - impact code.Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, although a periprosthetic joint infection and subsequent revision was reported, the clinical root cause of the infection cannot be confirmed; however, the reported infection is highly likely of an exogenous nature.The seroma is a known complication of surgery, and it cannot be concluded the reported seroma is associated with a mal performance of the implant or implant failure.The patient impact beyond the periprosthetic joint infection, seroma, and revision cannot be determined with the limited information provided.No further clinical assessment is warranted at this time.The device specific identifiers for the dual mobility insert were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and sterilization records review could not be performed.For the femoral head, 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 has been identified in the 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 historical review concluded that there are no prior actions related to this product and event.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect 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.

Manufacturer Narrative

H10.Additional information in a1, a2, a3, d10 and h6.

Manufacturer Narrative

B5: describe event or problem a2: age or date of birth and d6: if implanted, give date.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, although a periprosthetic joint infection and subsequent revision was reported, the clinical root cause of the infection cannot be confirmed; however, the reported infection is highly likely of an exogenous nature.The seroma is a known complication of surgery, and it cannot be concluded the reported seroma is associated with a mal performance of the implant or implant failure.The patient impact beyond the periprosthetic joint infection, seroma, and revision cannot be determined with the limited information provided.No further clinical assessment is warranted at this time.The device specific identifiers for the dual mobility insert were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and sterilization records review could not be performed.For the femoral head, 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 has been identified in the 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 historical review concluded that there are no prior actions related to this product and event.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect 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 Description

It was reported that, after undergoing left tha revision on (b)(6) 2022, the patient developed a seroma on the left hip for which he entered the surgical room on (b)(6) 2022, for an irrigation and debridement procedure with antibiotic bead placement.Days later, on (b)(6) 2022 the patient required a ct guided aspiration for left hip abscess removal.After this procedure, the patient was found to present a periprosthetic joint infection with persistent wound drainage.This event was addressed by performing a second left hip revision on (b)(6) 2022, in which the femoral head and liner were explanted and exchanged with new identical devices.The patient was then transferred to the hospital bed and taken to the recovery room in stable condition.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-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: 16911648
• MDR Text Key: 315005653
• Report Number: 1020279-2023-01016
• 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: K211176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71342800
• Device Catalogue Number: 71342800
• Device Lot Number: 20EM13764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 03/16/2024; 03/20/2024; 05/08/2024
• Supplement Dates FDA Received: 06/09/2023; 03/24/2024; 04/10/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2020
• 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: 74120162 / ACETLR CUP HAP 62MM W/ IMPTR; UNKN ANTHOLOGY HIP IMPL; UNKN BIRMINGHAM HIP RESURFACING (BHR) DUAL MOBILIT; UNKN BIRMINGHAM HIP RESURFACING (BHR) DUAL MOBILIT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male