MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 15; PROSTHESIS,HIP,SEMI-CONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED

Model Number 71306615

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the patient underwent thr surgery in the right hip on (b)(6) 2019, and experienced a right intraoperative calcar fracture.This adverse event was resolved by utilizing cables; however, it remains unclear what caused the fracture.The current health status of the patient is unknown.

Manufacturer Narrative

D11: concomitant medical products and therapy dates.H6: health effect - impact code and h8: usage of device.Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, improper implant alignment or placement, can increase risk of femoral or pelvic fractures, this has been identified as warnings and precautions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality and/or surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SYN POR FEM COMP SZ 15
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15535478
• MDR Text Key: 301091301
• Report Number: 1020279-2022-04271
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010194497
• UDI-Public: 03596010194497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 71306615
• Device Catalogue Number: 71306615
• Device Lot Number: 12BM16768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: R3 3 HOLE ACET SHELL 54MM, LOT#:17KW04548; R3 36MM ID US DELTA LINER 54MM OD, LOT#:17ET87456; R3 US DELTA HEAD 36 +0, LOT#: 18MT14202
• Patient Outcome(s): Required Intervention