MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM IMPACTOR ROD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71364011

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the tip of impactor rod broke off during stem implantation.

Event Description

It was reported the tip of impactor rod broke off during implantation and remains implanted in patient.

• Brand Name: STEM IMPACTOR ROD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 9013995009
• MDR Report Key: 6419528
• MDR Text Key: 70635148
• Report Number: 1020279-2017-00194
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2017

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 Catalogue Number: 71364011
• Device Lot Number: 08BM15057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/29/2017; 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other