MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRI SO 12/14 SZ 1; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED

Model Number	71312101
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of a thr was performed on (b)(6) 2009 as the femoral component was loose.The outcome of the patient is unknown.No further information is available at the time.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported femoral component loosing and revision cannot be determined.The patient¿s current health status is reportedly, ¿healthy.¿ it has been communicated, ¿no further information is available.¿ therefore, no further clinical/medical assessment can be rendered.Should any additional relevant medical information be provided, this case may be re-assessed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening of implant components, which may lead to revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

• Brand Name: SPEC EF PRI SO 12/14 SZ 1
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED
• 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: 15716051
• Report Number: 1020279-2022-04652
• Device Sequence Number: 6601006
• Product Code: MRA
• UDI-Device Identifier: 03596010195517
• UDI-Public: 03596010195517
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 71312101
• Device Catalogue Number: 71312101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/29/2022
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown