MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 71343204

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Arthralgia (2355); Joint Dislocation (2374)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced pain and dislocation.A revision surgery was performed on the (b)(6) 2023 to treat this adverse event in which a oxinium fem hd 12/14 32mm +4 was exchanged while a r3 20 deg +4 xlpe acet lnr 32mm x 50mm remained.In addition, the surgeon does not believe that the product is at fault.The current health status of the patient is unknown.

Event Description

It was reported that, after a thr revision was performed on (b)(6) 2022 (in which unknown devices were removed and s+n implants were placed), the patient experienced pain and dislocation.A second revision surgery was performed on (b)(6) 2023 in which the oxinium fem hd 12/14 32mm +4 was exchanged, while the r3 20 deg +4 xlpe acet lnr 32mm x 50mm remained in situ.It was indicated that the surgeon does not believe that the product is at fault.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the oxinium fem hd 12/14 32mm +4.Therefore, no investigation is deemed for the other device.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision total hip replacement was performed approximately nine months post implantation due to pain and dislocation.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.It is noted within the attachments that further patient information is unknown.Therefore, there were no clinical factors found which would have contributed to the reported pain and dislocation.However, it was reported that the surgeon does not believe that the product is at fault.The patient impact beyond the pain, dislocation, and revision cannot be determined.No further medical assessment can be rendered at this time.Device 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 similar events for the listed device, 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 dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.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.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: OXINIUM FEM HD 12/14 32MM +4
• 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: 17466809
• MDR Text Key: 320470631
• Report Number: 1020279-2023-01552
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474223
• UDI-Public: 03596010474223
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

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 Catalogue Number: 71343204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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: R3 20 DEG +4 XLPE ACET LNR 32MM X 50MM
• Patient Outcome(s): Required Intervention; Hospitalization