MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH PRI FEM COMP SO SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71341011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery to remove an echelon femoral stem due to complications with it.The primary surgery went successfully but after the completion of such surgery the patient had to return due to a feeling of pain.Upon checking x rays it was noticed that the previously implanted stem had perforated trough the proximal femoral shaft and a revision was planned immediately to preclude any further damage.Both the head and the stem were revised.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported fall with onset of increased pain within a month of the 2nd revision and the patient¿s bmi of 49.8 are likely potential contributing factors to the reported stem fracture and subsequent 2nd revision.The noted distal cortical thickening on the x-ray images may also indicate the presence of micromotion over a period of time and given that the proximal portion of the stem was ¿fairly easily¿ removed, may suggest that there was inadequate proximal femoral support; therefore, these findings also cannot be ruled out as possible contributing factors.The 2nd revision op-note documented diagnosis of ¿failure of recalled hardware of tha¿ was not confirmed, as the global field action qm indicated only an advisory notice for revising ceramic components [r-2016-24] had been issued.The definitive root cause of the reported event; however, could not be definitively concluded.The assessed patient impact was the reported pain, limp, revision with fluoroscopy-assisted distal stem removal and cerclage x 2.Further patient impact could not be determined.No further medical assessment can 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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.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 PRI FEM COMP SO SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10671981
• Report Number: 1020279-2020-05362
• Device Sequence Number: 11444965
• Product Code: JDI
• UDI-Device Identifier: 03596010438751
• UDI-Public: 03596010438751
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71341011
• Device Catalogue Number: 71341011
• Device Lot Number: 17EM22531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 07/13/2021
• 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