MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336500

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the threaded hole cover sunk straight through the cup and was unable to be removed, thus remains implanted in the patient.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.

• Brand Name: REFLECTION THREADED HOLE COVER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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 ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6276209
• MDR Text Key: 65707136
• Report Number: 1020279-2017-00056
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71336500
• Device Lot Number: 16BM17539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other