MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER

Model Number 71291302

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 06/07/2017

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to broken implant.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).

• Brand Name: EMP 13 STEM PRIMARY HO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 6632471
• MDR Text Key: 77272258
• Report Number: 1020279-2017-00406
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561497
• UDI-Public: 03596010561497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042127
• 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
• Report Date: 10/05/2017

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
• Device Expiration Date: 06/06/2021
• Device Model Number: 71291302
• Device Catalogue Number: 71291302
• Device Lot Number: 11FM05491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2011
• 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: 81 YR
• Patient Weight: 118