MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 60MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339160
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that a patient had a previous thr revision surgery been performed on (b)(6) 2024, where an r3 20 degree liner had been revised for a constrained liner.After that surgery the patient experienced a hip dislocation.The patient reported that it had been bending down in the garden and heard/felt a ¿pop¿.X-rays showed the hip had been dislocated.This adverse event was addressed by a revision surgery on (b)(6) 2025, in which the constrained liner, acetabular shell, and femoral head were removed and replaced.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation.However, the photographs were reviewed and revealed that the liner and femoral head are heavily deformed.The clinical/medical investigation concluded that, based on the limited information available, the clinical root cause of the hip dislocation cannot be confirmed.The incident occurred while the patient was bending down in the garden, and he felt and heard a pop, which led to the dislocation.Although trauma or extreme positioning might have contributed to the dislocation, this cannot be definitively determined.The provided x-ray confirmed the dislocation, and photos showed damage to the femoral head and liner, but it is unclear when and how this damage occurred.No further clinical documentation was provided to offer additional insights.For the liner and the femoral head, 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 devices did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, which may result from improper selection of the neck length and cup, stem positioning, muscle looseness, and/or malpositioning of components.A review of the risk management files revealed these failure modes were 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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.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 CONST 60MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 21379021
• Report Number: 1020279-2025-00276
• Device Sequence Number: 17100335
• Product Code: KWZ
• UDI-Device Identifier: 00885556021330
• UDI-Public: 885556021330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71339160
• Device Lot Number: 20JM11248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 DRILL BIT QC 110/85 GOLD: 71176025, 23DNX0001; COCR 12/14 FEM HEAD 28 -3: 71302803, 22DT62499; OXINIUM FEM HD 12/14 28MM +4: 71342804, 22HM20988
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male