MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEX IMPCTR HD 3-8; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71441554

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during a tka that while impacting the poly into the base plate, the head of a gii ps high flex impctr hd 3-8 split and broke.Some small pieces made it into the wound but the surgeon was able to locate them and remove it.It is unknown how the procedure was finished or if this caused a surgical delay.No patient harm reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file 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.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.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: GII PS HIGH FLEX IMPCTR HD 3-8
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12544551
• MDR Text Key: 273737688
• Report Number: 1020279-2021-07275
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010497376
• UDI-Public: 03596010497376
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441554
• Device Catalogue Number: 71441554
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention