MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF INTERFIT ACET NH SZ 56; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71334056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Osteolysis (2377)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that, a thr revision surgery had to be performed due to poly wear and osteolysis of the posterior column, the primary surgery had been performed fifteen (15) years ago.Patient was admitted following a fall.The acetabular components, rf interfit acet nh sz 56, ref lnr 28id 20 deg sz f, and ref interfit thrd hole cover were explanted, and replaced by s+n implants.Surgery outcome was satisfactory, x-ray showed cage sitting up slightly due to some superior osteophytes.Patient has gone to rehab and hip pain is gone.A sample from the theater grew staphylococcus, said to be a likely contaminant but two (2) weeks of antibiotics were prescribed.No other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a devices analysis could not be performed.The clinical/medical investigation concluded that, the reported poly wear is consistent with the liner remaining in vivo >15 years.The patient fall and the nondisplaced acetabular fracture are the likely causes of the subsequent revision.The osteolysis may have contributed to the susceptibility of the adverse advent.As it is noted, there was a ¿huge amount of lysis in posterior column but cup looked solid.However, there was ¿concern that with the fracture and posterior lysis of the cup would loosen and then fracture through the posterior column.¿ the patient impact is the pain, acetabular fracture, revision, positive staph culture and antibiotic treatment.The future impact cannot be determined; however, it is noted the patient¿s hip pain was gone.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in warnings and precautions, that the implant can break or become damaged as a result of trauma or activity including heavy labor for occupation or recreation.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 these product and event.At this time, we do have reason to suspect that the products failed to meet specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury or patient condition.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: RF INTERFIT ACET NH SZ 56
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 18110492
• MDR Text Key: 327881498
• Report Number: 1020279-2023-02191
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010197320
• UDI-Public: 03596010197320
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2011
• Device Catalogue Number: 71334056
• Device Lot Number: 01KM05314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71330001.; 71742854.
• Patient Outcome(s): Hospitalization; Other; Required Intervention