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

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the surgeon considered it is not the product failure, the products cannot be returned and that no more information are available.

Event Description

It was reported that revision surgery was performed due to loosening of acetabular cup.

• 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 ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6416622
• MDR Text Key: 70301030
• Report Number: 1020279-2017-00185
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: 03/07/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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