MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 4; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Model Number 71357004

Device Problem Break (1069)

Patient Problem Hip Fracture (2349)

Event Date 03/15/2021

Event Type  Injury  

Event Description

It was reported that, patient had a initial thr surgery on (b)(6) 2019.Patient suffered a fracture, the anthology so por pl ha sz 4 snapped at the neck juncture therefore it was necessary a revision surgery.Patient outcome is unknown.

Manufacturer Narrative

The devices, used in treatment, were returned for evaluation.A visual inspection of the returned implant confirms the stem has fractured.The visual also confirms the oxinium head is still attached.A lab analysis was conducted and the visual examination of the returned anthology stem with oxinium head exhibited a neck fracture.During this investigation no destructive testing was used.No material or manufacturing deviations were observed in this report.The stem component displayed on-growth over a large great percentage of the proximal coated area.The scoring and missing porous coating are most likely resulting from instrument contact during removal.The femoral head and neck component exhibited some scratches.The distal end of the stem also had some scoring present.The fracture surface was examined under the sem.Fatigue striations and mircovoid coalescence features were observed.The signs of microvoid coalescence indicate an overload region in the inferior aspect of fracture surface.Fatigue striations were observed in the superior/mid region of the fracture surface.These signs indicate the fracture initiation site was likely in the superior region of the neck.No determination of the reason for this fracture can be made from this investigation.A medical investigation was conducted and confirms based on the information provided, the clinical root cause of the reported revision could not be definitively concluded; however, the noted radiolucencies particularly along the proximal/medial stem and could not be ruled out as a contributing factor, and the original placement of the cup cannot be compared.The assessed patient impact was the reported stem fracture and the revision along with an anticipated transient convalescence phase.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation/information become available in the future, and/or if significant lab retrieval analysis findings are noted, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

Manufacturer Narrative

The devices, used in treatment, were returned for evaluation.A visual inspection of the returned implant confirms the stem has fractured.The visual also confirms the oxinium head is still attached.The clinical evaluation concluded that based on the information provided, the clinical root cause of the reported femoral neck fracture cannot be confirmed and it cannot be concluded that the femoral neck fracture and subsequent revision were associated with a malperformance of the implant.However, the noted radiolucencies particularly along the proximal/medial stem indicating possible micromotion could not be ruled out as a contributing factor, and the original placement of the cup cannot be compared.The patient impact beyond the reported pain, revision, and convalescence period cannot be determined.However, it is noted two weeks post revision, the patient was healing well without complications.No further clinical/medical assessment is warranted at this time.A lab analysis was conducted and the visual examination of the returned anthology stem with oxinium head exhibited a neck fracture.During this investigation no destructive testing was used.No material or manufacturing deviations were observed in this report.The stem component displayed on-growth over a large great percentage of the proximal coated area.The scoring and missing porous coating are most likely resulting from instrument contact during removal.The femoral head and neck component exhibited some scratches.The distal end of the stem also had some scoring present.The fracture surface was examined under the sem.Fatigue striations and mircovoid coalescence features were observed.The signs of microvoid coalescence indicate an overload region in the inferior aspect of fracture surface.Fatigue striations were observed in the superior/mid region of the fracture surface.These signs indicate the fracture initiation site was likely in the superior region of the neck.No determination of the reason for this fracture can be made from this investigation.A medical investigation was conducted and confirms based on the information provided, the clinical root cause of the reported revision could not be definitively concluded; however, the noted radiolucencies particularly along the proximal/medial stem and could not be ruled out as a contributing factor, and the original placement of the cup cannot be compared.The assessed patient impact was the reported stem fracture and the revision along with an anticipated transient convalescence phase.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation/information become available in the future, and/or if significant lab retrieval analysis findings are noted, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY SO POR PL HA SZ 4
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11627544
• MDR Text Key: 244200179
• Report Number: 1020279-2021-02781
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010559470
• UDI-Public: 03596010559470
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 71357004
• Device Catalogue Number: 71357004
• Device Lot Number: 19BM15309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 10/12/2021; 11/02/2021
• Supplement Dates FDA Received: 10/13/2021; 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention