MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 11; PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEMEN

Model Number	71306611
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an invasive surgical procedure due to a minor fracture of femur.
Event or Problem Description
It was reported that the patient underwent an invasive surgical procedure due to a minor fracture of the femur.No revision was reported.
Additional Manufacturer Narrative
Additional info: b5, d6, d10, h2, h3, h6, h10.Results of investigation: it was reported that the patient underwent an invasive surgical procedure due to a minor fracture of femur.The affected synergy porous stem, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch 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 the same 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.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that one pre-op and one post implant x-ray have been provided which show a stem subsidence and femoral fracture at the lesser trochanter.The provided operative report detailed the procedure without abnormal findings.Per communications, two days post-implantation, this patient sustained an injury.Two post-invasive surgery x-rays show a reduced fracture with cerclage wires.As a result, this patient had a prolonged hospitalization.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.The cause of fracture was probably due to the patient injury as stated.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SYN POR FEM COMP SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEMEN
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9520151
• Report Number: 1020279-2019-04598
• Device Sequence Number: 16280321
• Product Code: LPH
• UDI-Device Identifier: 03596010194459
• UDI-Public: 03596010194459
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: No Information
• Device Expiration Date: 04/11/2019
• Device Model Number: 71306611
• Device Catalogue Number: 71306611
• Device Lot Number: 09DM07931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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: 71331852-09AM17528; 71335752-08JM20970; 71343600-09GM13420; 71331852-09AM17528; 71335752-08JM20970; 71343600-09GM13420
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 81