MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 26X 50-52 20 DG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71742650

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

H10.Internal reference: (b)(4).

Event Description

It was reported that, after surgery had been performed on (b)(6) 2022, the patient experienced a clear zone in femur due to the ref lnr 26x 50-52 20 dg sz e wear.This adverse event was solved by revision surgery on (b)(6) 2023, in which the liner and the head were removed and s+n devices were implanted.It is unknown the current health status of patient.

Manufacturer Narrative

Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the acetabular liner and femoral head.The associated devices were returned and evaluated.The visual inspection of the returned liner reveals heavy discoloration and scratches in the device.The visual also reveals the head has heavy scratches around the connection point of the implant.Further testing revealed that this damage was likely caused by removal of the head from the hip stem during revision.The liner shows some damage and deformation and signs of absorbed biological fluid.A wear inspection was conducted by placing the femoral head into the acetabular liner and visually inspecting the fit between the mating components.A secure fit was unable to be achieved between the femoral head and acetabular liner demonstrating wear of the acetabular liner.A wear analysis was conducted using a silicone replication mold technique at 10x magnification.The maximum gap observed was of 2.88 mm over the life of the implant.There were no material and manufacturing issues of note during this investigation.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested supporting clinical documentation has not been provided.However, the acetabular liner was in situ for greater than 21 years, which is likely the clinical root cause of the reported radiolucent zone in femur due to the liner wear or stress shielding, but cannot confirm without associated images.The patient impact is the revision and postop convalescence period.No further clinical assessment is warranted at this time.The femoral head's batch number was not provided or present on the device, thus, an evaluation of the manufacturing records could not be performed.A review of the production order for the acetabular liner did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for both part numbers over the past 12 months and for the acetabular liner's 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 wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include lifetime of the device, friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.Should 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: REF LNR 26X 50-52 20 DG SZ E
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18367815
• MDR Text Key: 331047807
• Report Number: 1020279-2023-02541
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010232199
• UDI-Public: 03596010232199
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K932755
• 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: 04/22/2024

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 Catalogue Number: 71742650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71300026 / ZIRC 12/14 FEM HD 26 + 0; 71306612 / SYN POR FEM COMP SZ 12; 71330050 / REF FSO 5 50MM OD; 71336515 / UNIV CAN ACET SCREW 15MM
• Patient Outcome(s): Hospitalization; Required Intervention; Hospitalization; Required Intervention