MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71343612
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left hip tha first revision had been performed on (b)(6) 2018 to replace a bhr resurfacing system due to a metallosis diagnosis, the patient sustained an unspecified complication that made necessary a second revision on (b)(6) 2020.During this procedure, femoral head and acetabular liner were exchanged.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, as of the date of this medical investigation, supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported unspecified event and subsequent revision.The patient impact beyond the reported revision cannot be determined with the limited information provided.However, it is noted the patient had a 3rd revision 4-months later due to concern for prosthetic joint infection.A review of the production orders for the femoral head and acetabular liner 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 femoral head and acetabular liner over the previous 12 months, these similar events report the same harm but no sufficient information about the failure mode was provided, so these events could not be associated with the reported event.No adverse trend was found for this event.For the batch numbers, the review did not reveal similar events.A review of the instructions for use documents for total hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.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.
Additional Manufacturer Narrative
Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported unspecified event and subsequent revision.The patient impact beyond the reported revision cannot be determined with the limited information provided.However, it is noted the patient had a 3rd revision 4-months later due to concern for prosthetic joint infection.A review of the production orders for the femoral head and acetabular liner 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 femoral head and acetabular liner over the previous 12 months, these similar events report the same harm but no sufficient information about the failure mode was provided, so these events could not be associated with the reported event.No adverse trend was found for this event.For the batch numbers, the review did not reveal similar events.A review of the instructions for use documents for total hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.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.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• 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: 16542401
• Report Number: 1020279-2023-00522
• Device Sequence Number: 20399421
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2024

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 Model Number: 71343612
• Device Catalogue Number: 71343612
• Device Lot Number: 18KM09249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 05/08/2024
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/17/2023; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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: POLARSTEM STEM STD TI/HA 3 NON-CEM, LOT#:B1816297; R3 0 DEG XLPE ACET LNR 36MM X 62MM, LOT#:17DM01387; REDAPT MODULAR SHELL 62MM, LOT#:18HM11731
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male