MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71309114

Device Problem Compatibility Problem (2960)

Patient Problems Bacterial Infection (1735); Hip Fracture (2349)

Event Date 07/06/2017

Event Type  Injury  

Event Description

It was reported that, after an r3-tha surgery had been performed in the left hip, the patient experienced prosthetic joint infection, failed left hip replacement, peroneal nerve palsy resulting in footdrop, periprosthetic fracture at the level of the distal aspect of the stump.A revision surgery was performed to treat the adverse event.The patient outcome is unknown.

Manufacturer Narrative

Additional info: d4-lot # device evaluation: it was reported that a patient underwent a medically-indicated two-stage revision.All of the implanted devices were used in treatment.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, bhr head, hemi head, modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the r3 shell and stem.Similar complaints have been identified for the hemi head and r3 liner.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all device were sterilized.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The primary surgery was done in (b)(6) 2010.The ¿revision surgery was performed 7 years later due to prosthetic joint infection, failed left hip replacement, peroneal nerve palsy resulting in foot drop, periprosthetic fracture at the level of the distal aspect of the stump.¿ the intraoperative fracture of the femur required open reduction and internal fixation after the antibiotic spacer.Cables were used to reduce the fracture.The second stage was a; removal of hardware antibiotic spacer and cables were replaced.The prosthetic joint infection was likely a hematogenous sourced infection being 7 years post implantation.The root cause of the ¿peroneal nerve palsy¿ that resulted in foot drop cannot be concluded with the available information.It is also unclear what caused the periprosthetic fracture in the first stage of the revision.Without further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.(b)(4) d1-brand name.D4-part name.

• Brand Name: SYN POR HO FEM COM SZ 14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10216038
• MDR Text Key: 197082745
• Report Number: 1020279-2020-02850
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010459794
• UDI-Public: 03596010459794
• Combination Product (y/n): N
• PMA/PMN Number: K002996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71309114
• Device Catalogue Number: 71306114
• Device Lot Number: 09LM02744
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention