MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMAGE HA HIP SZ 9MM LEFT; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 76098231

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a tha system had been implanted on (b)(6) 2001, the image ha hip sz 9mm left cone fractured in a fall on a cruise ship on (b)(6) 2023.It is unknown whether the revision surgery has already occurred or not.Current health status is also unknown.

Event Description

It was reported that, after a tha system had been implanted on (b)(6) 2001, the image ha hip sz 9mm left cone fractured in a fall on a cruise ship on (b)(6) 2023.The revision surgery was performed on (b)(6) 2023 to replace the s+n stem and the merete bioball delta head with its adapter with an s+n sl mia stem and a ceramic head from an unspecified manufacturer.The patient underwent a subsequent revision surgery on (b)(6) 2023 to replace such a head after recurring dislocations.

Manufacturer Narrative

H10.Additional information in b5.

Event Description

It was reported that, after a tha system had been implanted on (b)(6) 2001, the image ha hip sz 9mm left cone fractured in a fall on a cruise ship on (b)(6) 2023.The revision surgery was performed on (b)(6) 2023 to replace the s+n stem and the merete bioball delta head with its adapter with an s+n sl mia stem and a ceramic head from smith+nephew.The patient underwent a subsequent revision surgery on (b)(6) 2023 to replace such a head after recurring dislocations.

Manufacturer Narrative

Additional information: d6b (explanted date), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.The visual inspection revealed the implant fractured into two pieces.The visual also reveals the ceramic head is still attached to the implant.The clinical/medical investigation concluded that, the provided photos of the explants and x-ray image dated (b)(6) 2023 validates the reported stem breakage.The acetabular cup remains in situ as well as the cemented non s+n insert.The fracture of the stem is likely related to the patient¿s fall as reported.Based on the information provided, there is no evidence of a malperformance of the implant.The impact to the patient is limited to the revision surgery and the associated recovery period.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.A review of the instructions for use documents for total hip systems revealed that fracture of the implant can occur as a result of trauma, strenuous activity, improper alignment, or duration of service.A review of the risk management file 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 product and event.According with inspection procedure, the part configuration should be verified per print.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique, patient anatomy, abnormal loading of limb, excessive forces and/or 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 for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: b5 (narrative), d9&h3 (sample returned for analysis), e4 (reporter did not submit a report to fda), h6 (health effect - clinical code).

• Brand Name: IMAGE HA HIP SZ 9MM LEFT
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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: 18052652
• MDR Text Key: 327128175
• Report Number: 1020279-2023-02131
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 76098231
• Device Lot Number: 501054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female