MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71342808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Medical device site infection (4845)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, 8 weeks after a right hip revision was performed, the patient developed increasing pain, drainage, and an erythema around the wound.His hip was aspirated, and the culture grew pseudomonas.The patient underwent a second revision surgery on (b)(6) 2021 to treat the right periprosthetic joint infection.During the revision, the dual mobility insert and the oxinium femoral head were explanted and replaced.The patient woke up from the procedure and was transferred to pacu in stable condition.No further information is available.
Additional 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 presence of pseudomonas is highly likely of an exogenous nature and there is no evidence that the chronic infection and subsequent revisions were associated with the implant.The patient impact was the incision and drainage and revisions.No further clinical assessment is warranted at this time.All documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The insert's specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and sterilization records review could not be performed.The femoral head's batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the femoral head, 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 that 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 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.Additionally, since the femoral head's batch number was not provided, a review of the sterilization records could not be performed.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors from an exogenous nature that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, 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.

• Brand Name: OXINIUM FEM HD 12/14 28MM +8
• Common Device Name: 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: 19271047
• Report Number: 1020279-2024-00905
• Device Sequence Number: 12539514
• Product Code: LZO
• UDI-Device Identifier: 03596010474179
• UDI-Public: 03596010474179
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: Health Professional
• Device Catalogue Number: 71342808
• Device Lot Number: UNKNOWN
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ACETLR CUP HAP 56MM W/ IMPTR, LOT#:078051; SYN POR FEM COMP SZ 18, LOT#:03AM03954
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male