MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 16 R; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71345516
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery caused by infection, when reviewed x-rays, it was noted that insitu echelon stem had subsided with radio lucency around the stem.The stem was found to be loose and was removed.There was massive bone loss noted.Surgeon decided to implant a long exeter stem to revise.
Additional Manufacturer Narrative
The associated echelon ha coated bowed stem was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Thus, the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation noted undated x-rays were also submitted which support the reported radiolucency around the right femoral stem and subsidence.The image quality isn¿t great but there may also still be an area of non-union on the lateral aspect under the mid region of the fracture plate as well as thinning of areas of the mid shaft femoral cortex.The stem loosening and subsidence could be related to osteolysis from the infection or could have been co-finding when diagnosing the reported infections.The root cause could not be determined based solely on the information provided.However, the massive bone loss, subsidence, and reported radiolucency could possibly have an effect.There is no evidence to support our device contributed to the reported infection.The impact beyond revision surgery is unknown.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, the complaint will be reopened.
Additional Manufacturer Narrative
The associated echelon ha coated bowed stem was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Thus, the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation noted undated x-rays were also submitted which support the reported radiolucency around the right femoral stem and subsidence.The image quality isn¿t great but there may also still be an area of non-union on the lateral aspect under the mid region of the fracture plate as well as thinning of areas of the mid shaft femoral cortex.The stem loosening and subsidence could be related to osteolysis from the infection or could have been co-finding when diagnosing the reported infections.The root cause could not be determined based solely on the information provided.However, the massive bone loss, subsidence, and reported radiolucency could possibly have an effect.There is no evidence to support our device contributed to the reported infection.The impact beyond revision surgery is unknown.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, the complaint will be reopened.

• Brand Name: ECHELON HA STD 260 BOW S 16 R
• Common Device Name: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8661513
• Report Number: 1020279-2019-02142
• Device Sequence Number: 2130179
• Product Code: MEH
• UDI-Device Identifier: 00885556024126
• UDI-Public: 00885556024126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2019

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 Catalogue Number: 71345516
• Device Lot Number: 13DM13617
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 05/10/2019
• Initial Report FDA Received Date: 06/02/2019
• Supplement Report FDA Received Date: 08/29/2019; 08/29/2019
• 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
• Patient Age: 70 YR