MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71343604

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

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Unequal Limb Length (4534)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed, in which a r3 0 deg xlpe acet lnr 36mm x 52mm was exchanged with a oxinium fem hd 12/14 36 mm m/+4 because the patient had a fracture just after first operation causing stem to subside this caused a shortened leg so it was needed to add length.No further information available.

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after a thr, a revision surgery was performed, in which a oxinium fem hd 12/14 36 mm m/+4 was exchanged with a oxinium fem hd 12/14 36 mm m/+12 because the patient had a fracture, causing stem to subside, this caused a shortened leg so it was needed to add length.Also a r3 0 deg xlpe acet lnr 36mm x 52mm was exchanged because the surgeon decided to follow a posterior approach, there was no liner failure.No further information available.

Manufacturer Narrative

H2: additional information ¿b5, h6: health effect - clinical code¿.H3, h6: although the relationship with the reported failure was directly associated to the stem, the involvement of the femoral head was investigated.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, the patient was revised due to the reported fracture resulting in stem subsidence, no information on the stem was provided or around the fracture.The definitive clinical root cause of the fracture is unknown as comparison imaging from the immediate post-op phase and/or following the patient reported fracture were not provided.It is unknown if the instructions for use for total hip systems document, was adhered to.Therefore, it cannot be concluded the reported events were associated with a mal performance of the implant or implant failure.Since the patient¿s outcome is unknown, the impact to the patient beyond the reported fracture, leg shortening, the subsequent revision and the expected transient post-operative period cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.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 in the warnings and precautions that congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non-compliance, etc.Can increase risk of femoral or pelvic fractures.Additionally, improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming may increase the risk of lengthening or shortening of the femur, which may lead to revision surgery.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition and/or surgical technique.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.

Event Description

It was reported that, after a thr had been performed on (b)(6) 2022, the patient had a femoral fracture.The stem, from unknown identity, subsided causing a shortened leg.A revision surgery was performed on (b)(6) 2023 to add length by exchanging from +4 to +12 the oxinium fem hd 12/14 36 mm m.The liner was exchanged for an anteverted configuration because the surgeon decided to follow a posterior approach; there was no liner failure.It is unknown how the fracture was addressed and whether the stem was retained or removed.Current patient's health status is unknown.

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 18387424
• MDR Text Key: 331288572
• Report Number: 1020279-2023-02567
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010477286
• UDI-Public: 03596010477286
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71343604
• Device Lot Number: 22EM12302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 02/14/2024
• Supplement Dates FDA Received: 01/16/2024; 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization