MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 44MM ID X 60 OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331106

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Event Description

It was reported that during a thr procedure, impacting surface broke off.No confirmation of delay has been received.Backup device available.No injury or impact to patient reported.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 20 DEG XLPE LNR 44MM ID X 60 OD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8819051
• MDR Text Key: 152015575
• Report Number: 1020279-2019-02726
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• PMA/PMN Number: K093363
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71331106
• Device Lot Number: 18CM23549
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1