MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR STD 260MM BOW SZ 13 L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71340413

Device Problems Break (1069); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Hip Fracture (2349); Joint Dislocation (2374); Thromboembolism (2654); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 05/19/2020

Event Type  Injury  

Event Description

It was reported that, after the patient had been implanted an echelon stem on (b)(6) 2014 during a revision surgery, the patient experienced a dislocation because the stem fractured.The patient underwent a revision surgery on (b)(6) 2020: only the femoral head, stem and accord wires were explanted.The patient has had complications since this procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, after the patient had been implanted an echelon stem on (b)(6) 2014 during a revision surgery, the patient experienced a dislocation because the stem fractured.The patient underwent a revision surgery on (b)(6) 2020: only the femoral head, stem and accord wires were explanted.The patient has had complications since this procedure, she suffered from dvt after the revision and was forced to be fitted with wound vac.The patient continued having recurrent dislocations and revision surgeries after this event.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the broken implant was confirmed.The clinical/medical investigation concluded that, the cause of the reported dislocation, stem fracture, pain and distal shaft fracture is likely multifactorial.The patient¿s comorbidities (including the documented pelvic deformity, osteopenia, spinal fusion, soft tissue deficiency and history of multiple dislocations and prior surgeries), the mixed manufacturer construct, and patient activity could not be ruled out as potential contributing factors; however, the clinical root cause could not be definitively concluded.The assessed patient impact was the fractured femur and stem, reported recurrent component dislocation, pain and the complex 4-hour revision.Additionally, on pod#2, a right upper extremity ¿nonocclusive thrombus¿ was noted on ultrasound in the brachial vein and medication administration was required.Thrombus formation is a known possible post-operative complication; however, the clinical root cause of the upper-extremity thrombus could not be determined.Of note, no s+n components were in-vivo at the time of the reported event.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.

• Brand Name: ECH POR STD 260MM BOW SZ 13 L
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10781732
• MDR Text Key: 214509409
• Report Number: 1020279-2020-06096
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010328984
• UDI-Public: 03596010328984
• Combination Product (y/n): N
• PMA/PMN Number: K983834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 71340413
• Device Catalogue Number: 71340413
• Device Lot Number: 13AM12331
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 07/14/2021; 08/17/2021
• Supplement Dates FDA Received: 07/20/2021; 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71340007, ACC 2.0MM COCR CABLE W/CLAMP, 13FSM0009; 71340007, ACC 2.0MM COCR CABLE W/CLAMP, 13FSM0019; 71340007, ACC 2.0MM COCR CABLE W/CLAMP, 13HSM0263; 71342800, 71340007(X3); 71342800, OXINIUM FEM HD 12/14 28MM +0, 12HM09763
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR