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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2021-07551
• Device Sequence Number: 11829765
• Product Code: MEH
• UDI-Device Identifier: 03596010561497
• UDI-Public: 03596010561497
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71291302
• Device Catalogue Number: 71291302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 01/21/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 10/27/2021; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 145 KG