MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF I POR ACET SHELL 48OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 743048

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 11/15/2023

Event Type  Injury  

Event Description

It was reported that, after surgery had been performed on (b)(6) 2004, the patient experienced a mobilization of the ref i por acet shell 48od.This adverse event was solved by revision surgery on (b)(6) 2023.It is unknown the current health status of patient.

Manufacturer Narrative

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

Manufacturer Narrative

Results of investigation: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the shell and the femoral head.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that as of the date of this medical investigation, the requested supporting clinical documentation has not been provided.However, the acet shell was in situ for greater than 19 years, which is a possible root cause of the reported mobilization of the shell.The patient impact is the revision and postoperative convalescence period.No further clinical assessment is warranted at this time.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 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 instructions for use documents for total hip systems revealed in warnings and precautions that correct selection of the neck length and cup, and stem positioning, are important.Muscle looseness and/or malpositioning of components may result in loosening of components.Additionally, 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.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.At this time, we have no evidence to conclude that the products 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, loss of ingrowth, osteolysis and/or traumatic injury.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: REF I POR ACET SHELL 48OD
• Type of Device: 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: 18426858
• MDR Text Key: 331776220
• Report Number: 1020279-2024-00003
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/09/2024

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 Expiration Date: 06/09/2007
• Device Catalogue Number: 743048
• Device Lot Number: 70500171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PN: 71302803 / LN: 04HM01539; PN: 71742846 / LN: 80308201A
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR