MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 190MM STR SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71340113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to broken prothesis.The placement of this prosthesis was a 3rd revision for a (b)(6) patient.
Additional Manufacturer Narrative
The associated echelon porous straight stem was returned and evaluated.A lab analysis conducted during this investigation indicated that no bone ingrowth was seen on the proximal or distal sections of the stem.The fracture surface on the proximal section is observed on the femoral stem; the fracture was likely due to fatigue.No manufacturing deviations were observed during this investigation.Our investigation including a review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The batch number was provided for the device.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the implanted devices failed to meet specifications.A clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6) on (b)(6) 2018.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.).Without supporting clinical/medical documents a thorough investigation cannot be performed.However, based solely on the product evaluation the root cause of the fracture was likely due to fatigue.Should additional clinical information become available this complaint can be re-assessed.

• Brand Name: ECH POR 190MM STR SZ 13
• 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: 8083827
• Report Number: 1020279-2018-02532
• Device Sequence Number: 2325512
• Product Code: LPH
• UDI-Device Identifier: 03596010328724
• UDI-Public: 03596010328724
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2019

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: 08/13/2022
• Device Catalogue Number: 71340113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 02/26/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/19/2019; 03/03/2019
• 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: 71420182/10HM10328HIP IMPLANT/ UNKNOWN LOT NUMBER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR