MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 190MM STR SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71340113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, four years after a thr surgery had been performed on 2014, the patient experienced sudden onset of thigh pain and inability to walk.The patient went to the hospital with pain on (b)(6) 2022.As a result of the evaluation of the patient, x-rays were taken on (b)(6) 2022 and showed that the echelon 190mm porous femoral component size 13 was fractured.This was addressed via revision surgery to explant the stem, the date of the revision is not known.Current health state of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: d10 (adding concomitant product), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated devices were returned and evaluated.A visual inspection of the returned device revealed the device is broke in half.A lab analysis revealed the stem fractured approximately 123 mm distally from the tip of the femoral trunnion.The proximal taper shows radial demarcations / discoloration at the stem-head junction possibly signs of bodily fluid.The proximal and distal portions of the stem had visual signs of bone on-growth, however no bone on-growth visible under the collar and 10-25mm distally from the collar, and proximal bone on-growth appeared sparce on the proximal portion of the stem.Several gouges observed on the proximal and distal portions of the stem were more than likely caused during the removal process.Observing the fractured surfaces of the femoral stem, it appears that both surfaces have been worn down significantly, possibly due to rubbing against each other prior to removal and/or during transportation.The specific site of fracture initiation or cause of fracture could not be determined during this investigation.Scratches seen on the outer surface of the cocr femoral head were possibly due to removal of the head from the stem and/or transportation.The female taper showed radial demarcations / discoloration at the head-stem junction.No material or manufacturing deviations were observed in this report.No destructive testing was performed.The clinical/medical evaluation concluded that suboptimal electronic copy x-ray appears to show a 3-cerclage-tha with a displaced mid-stem, periprosthetic femoral shaft fracture.Based on the appearance of lack of contact between the collar of the prosthesis and the proximal calcar on the single undated electronic x-ray copy provided, we are unable to rule out possible insufficient proximal support; however, this cannot be confirmed based on this image alone.The patient impact beyond the reported to sudden onset of pain and inability to walk and the revision cannot be determined.No further medical assessment can be rendered at this time.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 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 risk management files 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 review of instructions for use for total hip systems revealed in warnings and precautions that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include 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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ECH POR 190MM STR SZ 13
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16273473
• Report Number: 1020279-2023-00206
• Device Sequence Number: 7518765
• Product Code: JDI
• UDI-Device Identifier: 03596010328724
• UDI-Public: 03596010328724
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: 71340113
• Device Catalogue Number: 71340113
• Device Lot Number: 09GM04717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71302803 / LOT: 09LT37492
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown