MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331950

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

Patient Problems Unspecified Infection (1930); Joint Laxity (4526)

Event Date 08/02/2023

Event Type  Injury  

Event Description

It was reported that, after thr surgery had been performed on (b)(6) 2021 and a subsequent washout was performed due to an acute infection, the patient recently presented with another infection.This adverse event was solved with iv antibiotics and revision surgery on (b)(6) 2023, in which the oxinium fem hd 12/14 32mm +0, the polarstem valgus ti/ha, the r3 3 hole ha ctd acet shell 50mm and the r3 20 deg xlpe acet lnr 32mm x 50mm, were removed.The femoral stem was extremely well fixed, and the acetabular cup was much easier to remove, signifying it may have loosened.Patient is recovering from surgery as per expectations.

Manufacturer Narrative

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

Manufacturer Narrative

H6: health effect - clinical code and health effect - impact code.Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that although the clinical root cause of the infection cannot be confirmed, it is highly likely of an exogenous nature.As well, the clinical root cause of the possibly loosened acetabular cup cannot be definitively confirmed; however, it could be seen as a result of the infections.It cannot be concluded the reported infection and subsequent revision were associated with a mal performance of the implants or implants failure.The patient impact beyond the acute infection and revision cannot be determined with the limited information provided.Devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.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 devices did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection has been identified as a potential complication associated with total hip arthroplasty surgery, primary or revision.A review of the risk management files 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 products and event.Additionally, an sterilization records review could not be performed as the batch numbers were not available.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue, injury, patient condition and/or medical history.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: R3 3 HOLE HA CTD ACET SHELL 50MM
• 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: 17637692
• MDR Text Key: 322114668
• Report Number: 1020279-2023-01668
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 71331950
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OXNM FEM HD12/14 32MM+0(PN:71343200); PLRSTM VLGS TI/HA(PN:75102073); R3 20D ACT LNR32MMX50MM(PN:71337650)
• Patient Outcome(s): Hospitalization; Required Intervention