MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 10/17/2020

Event Type  Injury  

Event Description

It was reported that on literature review "the early- to medium-term results of a hemispherical, porous coated acetabular shell with multiple different bearing combinations are excellent with the exception of metal-on-metal", 2 patients had a dislocation while ambulating due to a cup position retroverted after a tha while using r3 acetabular shell and high offset porous-coated synergy stem.The events were treated by a revision surgery.Patients¿ outcome if unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Thompson, z., khoshbin, a., ward, s., waddell, j.P., & atrey, a.(2020).The early-to medium-term results of a hemispherical, porous coated acetabular shell with multiple different bearing combinations are excellent with the exception of metal-on-metal.International orthopaedics, 44(12), 2537-2543.Doi: doi.Org/10.1007/s00264-020-04817-1.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.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.Internal complaint reference: (b)(4).

• Brand Name: UNKN R3 SHELL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 13765569
• MDR Text Key: 287206479
• Report Number: 1020279-2022-01157
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 04/12/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Required Intervention