MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 260BW 15CAL SZ 12L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71340612
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed for removal of a smith&nephew prosthesis from the left knee of a patient due to increased problems caused by the prosthesis, which broke in the past and was patched inside the patient.
Additional Manufacturer Narrative
The associated echelon bowed porous stem was not returned for evaluation.However, device details were provided.Therefore, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with this batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical assessment noted that all attachments were reviewed.No clinically relevant supporting documentation was provided regarding the (b)(6) 2018 revision, therefore, a thorough medical investigation could not be performed.Should relevant clinical documentation be provided, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.
Event or Problem Description
It was reported that revision surgery was performed for removal of a smith&nephew prosthesis from the left hip of a patient due to increased problems caused by the prosthesis, which broke in the past and was patched inside the patient.
Additional Manufacturer Narrative
B5 field was updated.

• Brand Name: ECH POR 260BW 15CAL SZ 12L
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8479399
• Report Number: 1020279-2019-01359
• Device Sequence Number: 1846359
• Product Code: LPH
• UDI-Device Identifier: 03596010383969
• UDI-Public: 03596010383969
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2019

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 Expiration Date: 08/15/2016
• Device Catalogue Number: 71340612
• Device Lot Number: 90100808Y
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019; 03/15/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/10/2019; 07/14/2019
• 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: 56 YR