MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 190MM STR SZ 11; PROST, HIP, SEMI-CNSTRND, METAL/POLY, CEMENTED

Model Number	71340111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a thr performed on an unspecified date, the patient fell and experienced pain, on (b)(6) 2021.X-rays determined the break of echelon por 190mm str size 11 and patient is scheduled for a revision surgery.Current health status of patient is unknown.Revision surgery date to be performed, is unknown.
Event or Problem Description
It was reported that, after a right thr performed on (b)(6) 2018, the patient fell and experienced pain on (b)(6) 2021.X-rays determined the break of echelon por 190mm str size 11 and the patient underwent a revision surgery on (b)(6) 2021 to address this issue.The patient was stable after the revision.No further information was reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Section: h3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and confirm the reported fracture.The clinical/medical investigation concluded that, patient had right thr 11/02/2018.The translated operative note indicated, ¿when she was walking at her home, presented severe pain in the middle third of the right thigh in a bruise form, later a fall, deformity and significant functional limitation.It was reported radiology showed, ¿fatigue rupture of the middle third of the stem, and proximal femur fracture.¿ the provided x-rays were reviewed and confirm the reported fracture.The operative note reported, capillary and bone fragility and an ¿extended transfemoral osteotomy for removal of the proximal and distal segment of the broken stem.¿ 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 or surgical technique.Based on this investigation, the need for corrective action is not indicated.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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured into two pieces, rendering the device inoperative.Both of the fractured components were returned.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 the patient had right thr (b)(6) 2018.The translated operative note indicated, ¿when she was walking at her home, presented severe pain in the middle third of the right thigh in a bruise form, later a fall, deformity and significant functional limitation.It was reported radiology showed, ¿fatigue rupture of the middle third of the stem, and proximal femur fracture.¿ the provided x-rays were reviewed and confirm the reported fracture.The operative note reported, capillary and bone fragility and an ¿extended transfemoral osteotomy for removal of the proximal and distal segment of the broken stem.¿ 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, patient anatomy or abnormal loading of limb.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.

• Brand Name: ECH POR 190MM STR SZ 11
• Common Device Name: PROST, HIP, SEMI-CNSTRND, METAL/POLY, 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: 12541632
• Report Number: 1020279-2021-07253
• Device Sequence Number: 1442768
• Product Code: JDI
• UDI-Device Identifier: 03596010328700
• UDI-Public: 03596010328700
• Combination Product (Y/N): N
• Initial Reporter Country: VE
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2022

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: 11/20/2025
• Device Model Number: 71340111
• Device Catalogue Number: 71340111
• Device Lot Number: 15LM17623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 11/11/2021; 03/01/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/26/2021; 11/14/2021; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2015
• 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: UNKNOWN FEMORAL HEAD IMPLANT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 63 KG