MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335558

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  Injury  

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2023, the surgeon determined that the cup was "too anteverted".The revision surgery was done on (b)(6)2023, in which a dual mobility or3o liner was used for the bearing surface and the acetabular implants were revised to a redapt mod cup with less version than what was previously implanted.No delay was reported and the patient left surgery in good health.

Manufacturer Narrative

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

Manufacturer Narrative

Section h3, h6: 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 clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Per the complaint details, a revision was performed approximately 5 months post total hip replacement surgery due the cup positioning (¿cup was too anteverted¿).The patient was reportedly revised with a dual mobility or3o liner, and the acetabular implants were revised to a redapt mod cup with less version compared to the previously implanted component.The patient impact beyond the reported cup positioning (¿too anteverted¿) and revision cannot be determined.Reportedly, the patient left surgery in good health with no procedural delay reported.Therefore, no further clinical/medical assessment can be rendered.A review of the devices' 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 devices.A review of the instructions for use documents for total hip systems revealed in the warning and precautions that the appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.Correct selection of the neck length and cup, and stem positioning is important.A review for the devices' 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 this products and event.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 alignment, size selected, patient anatomy and/or procedural/user error.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.H6: medical device problem code.

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• 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: 17439608
• MDR Text Key: 320203827
• Report Number: 1020279-2023-01526
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598271
• UDI-Public: 03596010598271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335558
• Device Lot Number: 22FW10535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: R3 0 DEG XLPE ACET LNR 36MM X 58MM, LOT#:22JM15144
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female