MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 53MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Catalog Number 126653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Tissue Damage (2104); Joint Disorder (2373)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to us that patient underwent a revision surgery with removal of the implant as it was wearing out the acetabulum, replacing it with an acetabular cup and liner.It was reported that the surgeon does not fault the device.

Manufacturer Narrative

During investigation it was noticed that the explant includes an additonal device.

• Brand Name: TANDEM UNIPOLAR 53MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• 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 ; 0628320660
• MDR Report Key: 6334841
• MDR Text Key: 67535382
• Report Number: 1020279-2017-00105
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896580
• 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,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Catalogue Number: 126653
• Device Lot Number: 10CM07131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2010
• 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): Hospitalization; Required Intervention