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	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery to remove an echeleon femoral stem due to complications with it.The primary surgery went successfully but immediately after the completion of such surgery imaging revealed that there was a perforation of the femoral stem through the proximal femoral shaft.The event was resolved via revision surgery in which the stem and the head were removed.
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, based on the documentation provided, the root cause of the reported event was a user/procedural variance with the stem perforating the femoral shaft.The assessed patient impact was the femoral cortical defect/perforation requiring cerclage, additional imaging and the same-day revision procedure.Further patient impact could not be determined as reportedly, the construct provided excellent stability.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 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 are not limited to procedural/user variance.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: 10766577
• Report Number: 1020279-2020-05966
• Device Sequence Number: 1138985
• Product Code: JDI
• UDI-Device Identifier: 03596010438751
• UDI-Public: 03596010438751
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2021

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: 71357004
• Device Lot Number: 17KM18328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 08/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM HEAD 71343604, LOT 17EM18306
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention