MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 17; PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEM

Model Number 71306617

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 12/13/2010

Event Type  Injury  

Event Description

It was reported that during surgery the doctor had to make a medical intervention due to fissure at the femur.

Manufacturer Narrative

It was reported that during surgery the doctor had to make a medical intervention due to fissure at the 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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.It was communicated that this adverse event has been resolved, no further harm is being alleged to this patient.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to surgical technique or bone quality.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.

• Brand Name: SYN POR FEM COMP SZ 17
• Type of Device: PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9520494
• MDR Text Key: 172733358
• Report Number: 1020279-2019-04603
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010194510
• UDI-Public: 03596010194510
• Combination Product (y/n): N
• PMA/PMN Number: K963509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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
• Device Operator: No Information
• Device Expiration Date: 07/10/2020
• Device Model Number: 71306617
• Device Catalogue Number: 71306617
• Device Lot Number: 10GM06425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71331858-08LM08214.; 71335758-10CM14825.; 71343600-10KM07239.; ACETABULAR LINER, # 71335758, LOT # 10CM14825.; ACETABULAR SHELL, # 71331858, LOT # 08LM08214.; OXINIUM HEAD, # 71343600, LOT # 10KM07239.; 71331858-08LM08214; 71335758-10CM14825; 71343600-10KM07239
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77