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

Model Number 71291302

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a thr surgery had been performed on 2009, the patient experienced an unspecified adverse event.However, it was solved by a revision surgery on (b)(6) 2021, in which the emp 13 stem primary ho was found broken just proximal to the sleeve.An eto was required to remove the stem and an across stem was implanted.It is unknown current health status of the patient.

Event Description

It was reported that, after a thr surgery had been performed on 2009, the patient experienced severe pain.A revision surgery was performed on (b)(6) 2021 in order to solve this adverse event.The emp 13 stem primary ho was found broken just proximal to the sleeve.An eto was required to remove the stem and an across stem was implanted.It is unknown the patient current health status.

Manufacturer Narrative

H3, h6; the device was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, based on the information and imaging provided, the possible radiolucency and periprosthetic fracture around the stem could not be ruled out as a contributing factor leading to the stem breakage; however, the clinical root cause could not be definitively concluded.The assessed patient impact was the reported pain and stem fracture, along with the noted periprosthetic fracture and revision procedure.Further patient impact could not be determined.The current patient status was unknown per complaint.No further medical assessment can be rendered at this time.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.The contribution of the device to the reported event could not be corroborated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, surgical technique or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EMP 13 STEM PRIMARY HO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12624042
• MDR Text Key: 276149327
• Report Number: 1020279-2021-07551
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71291302
• Device Catalogue Number: 71291302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 145 KG