MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/

Model Number	71306614
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported, that a patient was hospitalized due to non-union of left femoral neck fracture after a synergy porous-coated stem sz 14 had been implanted and planned to undergo through a total hip arthroplasty.The patient had a large anterior femoral arch, and the synergy porous-coated stem sz 14 was slightly everted after surgery.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, per case details, ¿the patient was hospitalized due to nonunion of left femoral neck fracture and planned to undergo total hip arthroplasty.¿ reportedly, ¿the patient had a large anterior femoral arch, and the femoral stem was slightly everted after surgery.¿ the patient¿s current health status is ¿the patient recovered well after surgery.¿ no additional requested information was provided.Without clinically relevant information for evaluation, the root cause of the reported post-operative events cannot be definitively concluded.Further patient impact beyond the reported outcome of the ¿slightly everted femoral stem¿ could not be assessed.No further medical assessment could be rendered 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 additional complaints for the listed batch.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 procedural/user error, surgical complication or patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, per case details, ¿the patient was hospitalized due to nonunion of left femoral neck fracture and planned to undergo total hip arthroplasty.¿ reportedly, ¿the patient had a large anterior femoral arch, and the femoral stem was slightly everted after surgery.¿ the patient¿s current health status is ¿the patient recovered well after surgery.¿ no additional requested information was provided.Without clinically relevant information for evaluation, the root cause of the reported post-operative events cannot be definitively concluded.Further patient impact beyond the reported outcome of the ¿slightly everted femoral stem¿ could not be assessed.No further medical assessment could be rendered 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 procedural/user error, surgical complication or patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: SYN POR FEM COMP SZ 14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12750874
• Report Number: 1020279-2021-07827
• Device Sequence Number: 17337106
• Product Code: MRA
• UDI-Device Identifier: 03596010194480
• UDI-Public: 03596010194480
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2022

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: 71306614
• Device Catalogue Number: 71306614
• Device Lot Number: 20CM4939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/26/2021; 01/14/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/01/2021; 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2020
• 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 Sex: Unknown