MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN TANDEM BIPOLAR/UNIPOLAR IMPL; PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.The ring was taken off inside.Initial surgery was performed on (b)(6) 2020.The patient argued a strange sound.After this phenomenon, an x-ray showed dislocation.The rocking ring had not been rocked.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of wear and deformation along the outer edge.A dimensional evaluation of the returned device confirmed the stated failure mode.One of the device's feature was found to be out of specification.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that based on the results of the returned device evaluation, revealing that the shell was oversized by 0.002" and measures 0.104" and the out of spec groves, the combination of the two cannot be ruled out as contributing factors of the reported dislocation that required the revision surgery.Although the batch number for the device was not included in the capa or hhe corrective and preventive actions have been implemented to mitigate this problem.The impact to this patient beyond the revision 2 weeks post primary surgery is unknown.No further clinical/medical assessment 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.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.An assessment of historical escalated cases concluded that this device had a previous issue in which one or more of the device's features were out of tolerance.Corrective and preventive actions were implemented to mitigate the occurrence of this problem.A contribution of the device to the reported event could be corroborated as the dimensional issue found has the potential to cause assembly issues for the retaining ring.Possible causes could include but not limited to traumatic injury, patient anatomy, manufacturing deficiency, or abnormal loading of limb.This issue was evaluated through our internal quality process and determined that based on the low risk presented, 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: UNKNOWN TANDEM BIPOLAR/UNIPOLAR IMPL
• Type of Device: PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10192691
• MDR Text Key: 196380043
• Report Number: 1020279-2020-02712
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• 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
• Removal/Correction Number: 2000000592
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female