MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN SEL II POR SO 10/12 SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 71305413

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

Patient Problem Ambulation Difficulties (2544)

Event Date 10/02/2020

Event Type  Injury  

Event Description

It was reported that, after a tha had been performed, the patient reported walking difficulty due to angle mistakes that were made on surgery.The surgeon has stated that the devices were not defective.A revision surgery was performed to explant the synergy sel ii por so 10/12 sz 13 stem.The patient outcome is unknown.

Manufacturer Narrative

H6: annex g code added.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the patient underwent a revision surgery due to reported walking difficulty due to angle mistakes on index surgery.Per email communication, the requested surgical reports and x-rays are not available.However, it was stated that the surgeon indicated the devices were not defective.Therefore, patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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 SEL II POR SO 10/12 SZ 13
• 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: 10766847
• MDR Text Key: 214077441
• Report Number: 1020279-2020-05968
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K970337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71305413
• Device Lot Number: 18GM07824
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention