MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS BICON TITANIUM SHELL 3; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75013981

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 1999, the patient experienced a fall which caused dislocation and breakage of the acetabular shell.A revision surgery was performed on the (b)(6) 2023 to treat this adverse event.The current health status of the patient is unknown.

Manufacturer Narrative

A1: patient identifier, a2: age or date of birth, a3: sex, a4: weight and b7: other relevant history, including preexisting medical conditions:.

Event Description

It was reported that, after a thr revision surgery was performed on an undisclosed date in 2012, the patient experienced a fall on (b)(6) 2023 and it was noted that the hip had a dislocation and breakage of the acetabular shell.A revision surgery was performed on (b)(6) 2023 to treat this adverse event.During this procedure, the head and cup were exchanged.The current health status of the patient is unknown.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: three (3) complaint samples have been returned regarding this complaint case: plus bicon titanium shell 3; bicon me/me me/pe insert std 3/28non-cem; metal/metal metal ball head 28l.The focus of this complaint investigation lies on the plus bicon titanium shell 3.Upon visual inspection, the reported failure could be confirmed and the shell is fractured in three (3) pieces.Upon material assessment, no inhomogeneities around the assumed fracture initiation area were detected that could have acted as a fracture initiation point.A review of the product documentation did not detect any deviation that could have contributed to the reported failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of the device labeling revealed that the current ifu (lit.No.12.23, ed.03/21) states "joint dislocation" and "implant component fracture" of the component as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with similar failure mode.A medical evaluation has been performed on all documents and images provided as of this date.The reported dislocation and subsequent revision were noted to be caused by a patient fall.The patient impact beyond the reported revision and postop convalescence period cannot be determined with the limited information provided.No further clinical assessment is warranted at this time.Based on the available information and the performed investigation, the reported failure could be confirmed.As they are no inhomogeneities around the assumed fracture initiation area that could have acted as a fracture initiation point, upon material assessment, the root cause of the implant breakage and hip dislocation is traced to the patient's fall.Smith and nephew will continue to monitor this device for similar issues.This investigation is considered closed.The returned complaint samples will be returned to customer.Corrected data: b3 (occurrence date), b5 (narrative), d9&h3 (sample returned for analysis), d10 (concomitant accesories udpated).

• Brand Name: PLUS BICON TITANIUM SHELL 3
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17953256
• MDR Text Key: 325897253
• Report Number: 9613369-2023-00203
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 07611996001921
• UDI-Public: 7611996001921
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75013981
• Device Lot Number: 9904.130492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/23/2023; Not provided
• Supplement Dates FDA Received: 10/24/2023; 12/18/2023
• 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: BICON ME/ME ME/PE INSERT STD 3/28NON-CEM,; METAL/METAL METAL BALL HEAD 28L; PN: 75002698 / LOT: 9903.52.0282; PN: 75003793 / LOT: B0906136; PN: 75007734 / LOT: 622487; SL-PLUS STANDARD STEM 3 NON-CEMENTED
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 85 KG