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 Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Inflammation (1932); Necrosis (1971); Metal Related Pathology (4530)

Event Date 02/20/2021

Event Type  Injury  

Event Description

On the literature article named "catastrophic failure of femoral stem modular junction when combined with metal-on-metal bearing in comparison to ceramic-on-ceramic: a retrospective cohort study", it was reported that, after modular neck femoral stem systems had been implanted on 2 patients, 2 revision surgeries were performed due to stem-neck junction wear and corrosion, causing signs of adverse reaction to metal debris.During all surgical revision, yellowish fluid was encountered along with inflamed and necrotic periprosthetic tissues.Stem-neck modular junction presented signs of corrosion with black debris associated with trunnion and stem pocket damages.In these cases, subtler signs of head trunnionosis were detected.These revision surgeries were performed after a mean of 43 months from the primary surgery.The patient outcomes are unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that per email correspondence, the requested information is not available.Without the requested patient-specific clinical information/documentation, further assessment of the reported events cannot be provided, and the root cause beyond those reported in the article could not be concluded.The patient impact beyond the reported events could not 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: 11817012
• MDR Text Key: 250359985
• Report Number: 1020279-2021-04168
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

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: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention