MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 11 STEM PRIMARY HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 71291102

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Implant date: is approximation as only the year is known.Udi: (b)(4).

Event Description

It was reported that patient underwent a revision surgery due to femoral stem fracture.It was reported that patient was apparently lifting something heavy, didn¿t fall but the stem fractured.There aren't any evidence of any periprosthetic fractures.The stem was difficult to remove.

Event Description

Femoral stem, sleve, head, and acetabular insert have been revised.

• Brand Name: EMP 11 STEM PRIMARY HO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 6383315
• MDR Text Key: 69205246
• Report Number: 1020279-2017-00158
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042127
• 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,Followup,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71291102
• Device Lot Number: 09KM14223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• 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
• Patient Age: 43 YR
• Patient Weight: 105