MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SMF SHORT MODULAR FEM STEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01100204

Device Problem Corroded (1131)

Patient Problem Metal Related Pathology (4530)

Event Date 10/31/2018

Event Type  Injury  

Event Description

On the literature article named "modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty", it was reported that, after a smf stem had been implanted on 4 patients, 4 revision surgeries were performed due to adverse reaction to metal debris.During these surgeries, blackened corroded debris was observed at the junction between the stem and the modular neck.All stems were well fixed and required an extended femoral osteotomy for their removal.The bearings were changed to ceramic on ceramic.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical medication evaluation could not be performed without patient-specific surgical records and x-rays, further assessment of the reported events cannot be provided, and the root cause beyond those reported in the article cannot be concluded.The patient impact beyond the reported events cannot be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include damaged product, implant corrosion or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: UNKN SMF SHORT MODULAR FEM STEM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11819594
• MDR Text Key: 250450137
• Report Number: 1020279-2021-04206
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100204
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention