MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 +0; PROST, KNEE, FEMTIBIAL, SEMI-CNSTRND, CMNTD, MET/POLY

Catalog Number 71369721

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

It was reported that after decontamination it was noticed the bottom of the head was broken.No procedure-related.Therefore, no injuries or surgical delays were reported.

Manufacturer Narrative

Additional information in: d4 (udi number), d9, g1 (mdr reporting contact name and address), g5.Corrected data in: d1, d2, d3, d4, g1 (manufacturing site name and address).

Manufacturer Narrative

H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The bottom of the device is fractured rendering it inoperable.The fractured pieces were not returned.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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: MI TRIAL FEM HEAD 36 +0
• Type of Device: PROST, KNEE, FEMTIBIAL, SEMI-CNSTRND, CMNTD, MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10788388
• MDR Text Key: 214750915
• Report Number: 9613369-2020-00225
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71369721
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 06/02/2021
• Supplement Dates FDA Received: 12/28/2020; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1