MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 11 STEM PRIMARY SO; PROSTHESIS, HIP, SEMI-CONS, UNCEME, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Model Number	71291101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a revision surgery was performed due to an emperion stem size 11 brokage.The broke stem was removed with an eto and replaced with stryker restoration.There is no information of when or where stem was implanted.No additional details were provided.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical / medical investigation concluded that, this case reports the revision of a fractured emperion stem.Per email correspondence, there is no relevant supporting medical documentation or additional information regarding the patient or the circumstances surrounding the fracture.A single x-ray confirms the stem fracture.The patient impact beyond the revision cannot be determined.Without the requested information, no further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures 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 and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury, excessive forces applied to implant, excessive pressure on the joint or abnormal loading of limb.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 11 STEM PRIMARY SO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, UNCEME, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11196840
• Report Number: 1020279-2021-00484
• Device Sequence Number: 16310231
• Product Code: MEH
• UDI-Device Identifier: 03596010561374
• UDI-Public: 03596010561374
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71291101
• Device Catalogue Number: 71291101
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 28 YR