MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF FXD NECK SIZE 5 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71352709
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: case(b)(4).
Event or Problem Description
It was reported that a revision surgery took place because the neck of the smf fxd neck size 5 ho was fractured.Primary surgery took place one year ago.Additionally a revision of the cup took place between the other two events previously described, all available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken/fractured and has signs of wear and tear from use.The device was manufactured in 2018.According to clinical/medical investigation, this case reports that the patient underwent two revision surgeries within two years, following a tha.The first revision replaced the r3 3 hole acet shell, however the reason for the replacement is unknown.A second revision was performed a year later, due to a fractured smf hip stem.Undated x-rays were provided, which confirm the reported stem fracture.However, per email correspondence, the requested surgical records are not available.Therefore, due to the limited information provided, a thorough medical assessment cannot be rendered, and the clinical root cause of the fractured stem cannot be determined.Should additional clinically relevant documentation become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history revealed no prior complaints for the listed part/lot.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken/fractured and has signs of wear and tear from use.The clinical/medical evaluation concluded that this case reports that the patient underwent two revision surgeries within two years, following a tha.The first revision replaced the r3 3 hole acet shell, however the reason for the replacement is unknown.A second revision was performed a year later, due to a fractured smf hip stem.Undated x-rays were provided, which confirm the reported stem fracture.However, per email correspondence, the requested surgical records are not available.Therefore, due to the limited information provided, a thorough medical assessment cannot be rendered, and the clinical root cause of the fractured stem cannot be determined.Should additional clinically relevant documentation become available, the clinical/medical task may be re-evaluated.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal reference number: case (b)(4).

• Brand Name: SMF FXD NECK SIZE 5 HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 11479285
• Report Number: 1020279-2021-02133
• Device Sequence Number: 3625296
• Product Code: LPH
• UDI-Device Identifier: 00885556159545
• UDI-Public: 00885556159545
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71352709
• Device Catalogue Number: 71352709
• Device Lot Number: 18DM21557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 02/22/2021; 03/18/2022
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/23/2021; 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Weight: 172 KG