MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED

Model Number 71335558

Device Problems Failure to Osseointegrate (1863); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Discomfort (2330); Arthralgia (2355); Joint Dislocation (2374)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, over the course of two weeks following a right tha had been performed on (b)(6) 2022, the patient experienced pain and discomfort because the prosthesis loosened and moved.On (b)(6) 2022, x-rays showed the failure.A revision surgery was performed on (b)(6) 2022 to replace the failed parts, which set the recovery time back by approximately three weeks.Patient's current health status is unknown.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the patient experienced pain and discomfort due to the total hip arthroplasty implant loosening and moving.As a result, the patient had a revision surgery approximately three weeks post implantation.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers 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 warnings and precautions that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants.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 these 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.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, size selected, patient condition and/or postoperative care.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.

Event Description

It was reported that, after a thr surgery of the right hip, performed on (b)(6) 2022 due to osteoarthritis, on (b)(6) 2022 the patient experienced a sudden and extremely sharp pain which caused disturbance of movement.On (b)(6) 2022 an x-ray was performed, and it revealed a dislocation of the acetabular liner with an anterior subluxation of the femoral head.This adverse event was treated with a revision surgery on (b)(6) 2022, where the acetabular cup was repositioned and adjusted to decrease anteversion and slightly increase abduction, and the femoral head and the acetabular liner were exchanged.Currently, patient is doing well and is not using a walker or a cane.

Manufacturer Narrative

H10: additional information in d9.H3, h6.The associated devices were returned and evaluated.A visual inspection of the returned devices reveal scratches and signs of wear.The clinical/medical investigation concluded that, per the surgical technique the final position for the acetabular component should be approximately 45 degrees of abduction and 20 degrees of anteversion.However, the revision operative reported indicated the acetabular cup was repositioned by decreasing anteversion and increasing abduction multiple times until the acceptable alignment was achieved.It is unknown whether the initial position of the acetabular cup led to the reported dislocation of the liner and subluxation of the femoral anterolaterally head which in turn resulted in the burnishing of the femoral head and pain.It cannot be concluded that the reported clinical symptoms were associated with a malperformance of the implant.The patient reported to be doing well and is not using a walker or cane.No further clinical/medical investigation is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the shell, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the liner and the head, a review of complaint history revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, 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 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 these 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.Factors that could contribute to the reported event include traumatic injury, patient anatomy and/or abnormal loading of limb.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.H11.Corrected information in h6 (health effect - clinical code and medical device problem code).

Manufacturer Narrative

The associated devices were returned and evaluated.A visual inspection of the returned devices reveal scratches and signs of wear.A lab analysis reveals no deviations from processing or material specifications were noted for any of the components.From visual observation and information provided, no conclusions can be made as to what initiated the wear on the femoral head, the scratches on the spherical head screws, or the threaded hole cover.The clinical/medical evaluation stated that the revision operative report indications noted x-rays revealed dislocation of the acetabular liner with a subluxation of the femoral head anterolaterally.The revision operative reported indicated the acetabular cup was repositioned by decreasing anteversion and increasing abduction multiple times until the acceptable alignment was achieved.It is unknown whether the initial position of the acetabular cup led to the reported dislocation of the liner and subluxation of the femoral anterolaterally head which in turn resulted in the burnishing of the femoral head and pain.It cannot be concluded that the reported clinical symptoms were associated with a malperformance of the implant.The patient reported to be doing well and is not using a walker or cane.No further clinical/medical investigation is warranted at this time.A review of the manufacturing records 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 shell, femoral head and the acetabular liner over the previous 12 months, but no similar events for their batches based on the historical data.For use 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 and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy and/or abnormal loading of limb.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• Type of Device: PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED
• 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: 16297600
• MDR Text Key: 308784588
• Report Number: 1020279-2023-00246
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598271
• UDI-Public: 03596010598271
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335558
• Device Catalogue Number: 71335558
• Device Lot Number: 22EW04847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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: 71332530/21DB01212/SPHER HEAD SCREW 30MM; 71332530/22FB00615/SPHER HEAD SCREW 30MM; 71335758/22GM00404/R3 20 DEG XLPE ACET LNR 36MM; 71336500/22FM14711/THREADED HOLE COVER; 71343603/22GM09539/OXINIUM FEM HD 12/14 36 MM -3; 75018404/C2208519/POLARSTEM COLLAR STD. TI/HA 4
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 93 KG