MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331952

Device Problem Failure to Osseointegrate (1863)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a thr had been performed on (b)(6) 2022 date, the patient experienced aseptic loosening and an acetabular fracture.Periprosthetic fracture of the acetabulum was not noticed when the shell was inserted during the primary, ongoing groin pain from an early stage post-op never settled.A revision surgery was performed on (b)(6) 2023, to address this adverse event.Surgeons removed, one (1) r3 3 hole ha ctd acet shell 52mm, one (1) r3 20 deg xlpe acet lnr 32mm x 52mm and one (1) ref spher head screw 30mm; the exeter stem was left in situ.Little to no bony ingrowth was found on the back of the r3 cup, the surgeon described it as a biological failure of unknown cause.Substantial osteolysis was found in the acetabulum with some contained defects, especially around the screw hole and fracture site.All the poor bone and impacted bone graft were removed.A 56/52 contour reconstruction ring was implanted with 11 reflection screws and then cemented in a 47mm polarcup with 28mm stainless steel head on the exeter stem.Patient is currently very well discharged.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the r3 3 hole ha coated acetabular shell 52mm.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without supporting clinical documentation, a clinical root cause of the aseptic loosening and acetabular fracture cannot be confirmed.The patient impact is revision.It is noted the patient is doing very well.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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 to minimize the risk of acetabular shell loosening in uncemented applications, surgeons should consider the use of orthopedic bone fixation devices such as bone screws, spikes, pegs, fins, or other bone fixation devices.Additionally, failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service could increase the risk of loosening, bending, cracking, or fracture of implant components, which may lead to revision surgery.This has been identified as a warning and precaution and as an adverse event in primary and 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 specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, lack of ingrowth, and/or osteolysis.Based on this investigation, the need for corrective action is not indicated.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: R3 3 HOLE HA CTD ACET SHELL 52MM
• 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: 18021335
• MDR Text Key: 326727475
• Report Number: 1020279-2023-02055
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597748
• UDI-Public: 3596010597748
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K201701
• 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: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71331952
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention