MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 0 DEG 50-52 SZ E; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71332071

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/02/2020

Event Type  Injury  

Event Description

It was reported that, after the initial surgery, the patient experienced dislocation or disassociation.A revision surgery was performed on (b)(6) 2020 in order to address such event.The patient outcome is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).The associated device, used in treatment, was returned and evaluated.The contribution of the device to the reported event could not be corroborated.The lab analysis concluded that the as-received components had no destructive analysis performed.No material or manufacturing deviations were observed.The shell component shows bone on-growth on the porous region of the shell and increased wear on the inner diameter of the shell.The oxinium head shows signs of damage to the oxide region of the oxinium head.Discoloration likely due to absorbed biological fluid was observed on the backside of the liner.The liner was also received in two pieces.The rim region of the liner was fractured.These findings suggest femoral head or hip stem neck impingement and/or dislocation occurred in-vivo.The clinical/medical evaluation concluded that per complaint details, a revision was performed 6 days post tha implantation due to ¿dislocation or disassociation¿.It was communicated that no further information was available for inclusion in the medical investigation.Although no patient injury or surgical delay was reported, the patient outcome remains unknown.The root cause and/or patient impact beyond that which was reported could not be further assessed.Should clinically relevant documentation/information and/or updated, relevant product evaluation results become available, the clinical/medical task may be re-evaluated.No further medical assessment could be rendered at this time.A review of complaint history did not reveal similar events for the listed device.At this time, we do not 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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.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: REF XLPE 32 0 DEG 50-52 SZ E
• 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: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11449963
• MDR Text Key: 238810645
• Report Number: 1020279-2021-01941
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• 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
• Treatment: SHELL 71335152, LOT 08LM18118
• Patient Outcome(s): Hospitalization; Required Intervention; Other