MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY SO; PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS

Model Number 71291301

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported that, a revision surgery was performed on (b)(6) 2021 due to the fracture of an emp 13 stem primary so implanted 10 years ago and revised to a long stem echelon.During the surgery, the emp 13 stem primary so, the emp13 slv sm cone 1 spout and the biolox delta head 36 mm 12/14 m / +4 were explanted.Extensive osteotomies were performed due to the significant ingrowth of bone onto proximal sleeve.Moreover, the shell and the ceramic liner were left untouched.The explanted devices are not able to be evaluated.No further information available regarding the post operative condition of patient is available.

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, based on the limited clinical information provided and without the return of the explant the clinical root cause of the reported stem fracture could not be concluded but relationship to the femoral deformity cannot be excluded as a contributing factor.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or excessive forces applied to implant.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.

• Brand Name: EMP 13 STEM PRIMARY SO
• Type of Device: PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS
• 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: 12804686
• MDR Text Key: 280703107
• Report Number: 1020279-2021-08116
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561480
• UDI-Public: 03596010561480
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71291301
• Device Catalogue Number: 71291301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• 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: A
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male