MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 STRAIGHT SHELL IMPACTOR; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71364450

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 11/21/2017

Event Type  Injury  

Event Description

It was reported that when doctor was about to impact shell implant, the weld broke on the impactor causing it to break apart into several pieces.

Manufacturer Narrative

After further review, it was determined that this report was filed in error.Please disregard.If further information is obtained that changes this determination, the investigation will be re-opened.

• Brand Name: R3 STRAIGHT SHELL IMPACTOR
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poektter ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 7095411
• MDR Text Key: 94103543
• Report Number: 1020279-2017-01188
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010607034
• UDI-Public: 03596010607034
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71364450
• Device Lot Number: 15CSA0017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other