MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMAGE HA HIP SZ 13MM LEFT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 76098235

Device Problems Break (1069); Material Erosion (1214)

Patient Problems Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 05/05/2020

Event Type  Injury  

Event Description

It was reported that the patient presented a fall earlier in the year, with a completely symptom-free interval.After that, the patient had presented a crack sound in the left hip when he was tried to bend down or move.A revision was carried out, where it was possible to observe a fracture of the ceramic head with the destruction of the femoral neck.For this reason, a change of head, the femoral neck and the insert were necessary.The insert was removed because it's necessary to do it the change of head and femoral neck and was also found loose.

Manufacturer Narrative

The associated device was returned and evaluated.Visual inspection of retrieved 13mm left image hip stem revealed deformation wear on the proximal male taper and femoral neck, significant scarring and scratches on the neck and around the removal slot, deep gouging on the proximal portion of the stem, and bone on growth on the proximal textured / grooved portion of the stem.The proximal male taper deformation wear is more than likely due to direct contact and repetitive articulation on the acetabular components.Scratches and scarring to the neck region were probably caused by contact with the femoral head debris.Gouging and scarring to the proximal portion of the stem is commonly seen after the revision process, where a sharp instrument is used to remove the implant.Bone on growth indicates that the stem was well fixed in the femoral canal, as intended by design.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.The clinical/medical evaluation concluded that this complaint from germany reports a revision was performed after a fall and cracking noise developed in the left hip.Surgery revealed a fracture of the ceramic head and destruction of the shaft cone.The stem, head and the inlay were changed out.Only the report that the surgery had been done was provided.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.It is unclear if the fall precipitated the event.Impact to the patient cannot be determined beyond the surgery and recovery.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 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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury.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: IMAGE HA HIP SZ 13MM LEFT
• 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: 11593531
• MDR Text Key: 243092994
• Report Number: 1020279-2021-02565
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010389312
• UDI-Public: 3596010389312
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 76098235
• Device Lot Number: 03ET74092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other