MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR STR 15MM CAL SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71340211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to implant fractured inside the patient.
Additional Manufacturer Narrative
The associated complaint device was returned to be evaluated.The visual inspection of the returned device shows the femoral stem was found to be fractured at a distal distance of approximately 104 mm from the head center.The distance from fracture surface to the end of the porous region is approximately 57 mm on distal piece of the returned stem.The cocr femoral head appears to be 22 mm in diameter.Visual scratches were noted on the polished neck.The head did not exhibit any visual scratching.No sign of bone on-growth on the porous region of the proximal piece.The distal piece does exhibit some attached material extending from the distal beginning of the porous beads to a distance of approximately 28 mm.Some porous beads are missing just distal to the fractured surface on the lower piece were observed.No other visual observations were made.No material or manufacturing deviations indicated from this investigation.No determination of the reason for fracture could be made.A review of complaint history revealed no prior complaints for the listed part.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical team concluded based on the limited information, the root cause for the stem breakage cannot be confirmed but poor bone support in the proximal portion of the stem and weakened bone support at the old fracture site could have played a role.Trauma, fall or other accident, though not reported, cannot be ruled out a contributing factor.No information on the patient¿s current has been provided at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: ECH POR STR 15MM CAL SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7265581
• Report Number: 1020279-2018-00160
• Device Sequence Number: 19128914
• Product Code: JDI
• UDI-Device Identifier: 03596010328809
• UDI-Public: 03596010328809
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2018

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: 07/12/2020
• Device Catalogue Number: 71340211
• Device Lot Number: 10GM08443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/07/2018; 02/07/2018; 02/07/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 02/13/2018; 02/15/2018; 05/08/2018
• 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: 41 YR