MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OFFSET REF CUP POS/IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71364022

Device Problems Crack (1135); Fracture (1260)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that, during a tka, the impactor cracked mid case, this was noticed after the acetabular liner was implanted safely with no issues.Surgery was performed, without any delay, with a s+n back-up device.Patient was not harmed as consequence of this problem.Furthermore, after surgery, while cleaning, the cracked piece of the impactor broke off.Since the breakage occurred after surgery, patient was no longer involved.

Manufacturer Narrative

Internal complaint number: case: (b)(4).

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Device damage (cracks) may cause minor or temporary injury (e.G.Abrasion, laceration, etc.) requiring no or minor medical intervention.Event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable pursuant to 21 cfr §803.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: OFFSET REF CUP POS/IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18540380
• MDR Text Key: 333542507
• Report Number: 1020279-2024-00166
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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 Catalogue Number: 71364022
• Device Lot Number: 15MM08530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1