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

Catalog Number	71340413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery needs to be performed due to the fracture of the stem.
Additional Manufacturer Narrative
The associated echelon porous stem was not made available for evaluation.After repeated requests, smith and nephew cannot obtain enough information about the patient conditions.However, device details were provided.Thus, a review of complaint history was performed.The device was manufactured in 2004.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Should additional clinical information become available in the future, the medical assessment may be re-evaluated.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to the stem fracture.The associated echelon porous stem was returned for evaluation along with wire fragments, the head and the liner.The markings on the last two components confirm these to be from another manufacturer.Mixed-use of competitor parts with sn devices is contraindicated.The origin and use of wires relative to the other items cannot be determined from the information provided.The stem was found to be broken at the approximate transition of the medial side curve and the cylindrical section.This is roughly a distance 110 mm-vertical from the center of the head to the fracture surface, which is common for proximal stem fractures.Visual inspection of the distal section found it to be significantly encased in bone cement.The cement mantle appeared to be approximate 4 mm thick.The proximal stem section porous region did not show any evidence of cement or biological attachment.This suggests minimal support in the proximal region.The fracture surfaces reveal failure due to overloading the section.Lack of proximal support allowed overloading of the fracture area, which ultimately resulted in stem fracture.A clinical analysis confirmed tibial fracture based on the provided x-ray.The root cause cannot be concluded due to the limited documentation provided however, the neck of the ball head and long neck of the stem can add extra leverage and the previous complex placement of the stem, and cannot be ruled out as a contributing factor of the stem fracture.Additionally, it is unknown if there were any traumatic injury or comorbid conditions that may have been contributing factors.

• Brand Name: ECH POR STD 260MM BOW SZ 13 L
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8327746
• Report Number: 1020279-2019-00518
• Device Sequence Number: 1739704
• Product Code: JDI
• UDI-Device Identifier: 03596010328984
• UDI-Public: 03596010328984
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 71340413
• Device Lot Number: 04MM13791A
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019; 01/21/2019; 01/21/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/30/2019; 07/15/2019; 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention