MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE HEAD 28 MM 12/14 L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 526971

Device Problem Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 10/05/2021

Event Type  Injury  

Event Description

It was reported that, after a tha had been implanted on (b)(6) 2001 with a ceramic-on-ceramic reflection/bhs system, the patient experienced a squeaking hip phenomenon for approximately a year, up until the point that the patient considered it disruptive.This incident was addressed via revision surgery on (b)(6) 2021 by exchanging the ceramic bearings for a cemented zimmer-biomet allofit durasul alpha insert and a merete bioball ceramic head with adapter.The cup and stem remained in place.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions), h8 (usage of the device).Results of investigation: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the patient had a left cementless total hip arthroplasty with the use of an stem, reflection cup, and ceramic articulation in may of 2001.It was reported that the patient experienced a squeaking hip for approximately one year that eventually became increasingly disruptive to the patient and a revision surgery was performed 20 years post implantation.Ceramic-ceramic wear was suspected.However, radiological and scintigraphic findings were unremarkable.Additionally, the revision operative report indicated the ceramic head and insert showed no wear or damage.The insert and head were replaced with non smith and nephew components.The stem and acetabular component remained in situ.It was noted that due no further implant availability because of the old implants, the decision was made to cement the polyethylene insert.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the information provided, there were no clinical factors identified which would have contributed to the reported squeaking hip.Noise is a possible risk from a ceramic on ceramic bearing.The patient impact includes the squeaking and subsequent revision surgery as well as associated recovery 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 numbers over 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 adverse events that temporary or permanent device related noise such as clicking, squeaking, popping, grating, or grinding, may lead to implant failure and revision surgery.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 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, wear and/or patient condition.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.Corrected data: b1 (type of event).

Manufacturer Narrative

Corrected data: b3 (occurrence date).

• Brand Name: BIOLOX FORTE HEAD 28 MM 12/14 L/+8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 18301734
• MDR Text Key: 330174460
• Report Number: 1020279-2023-02460
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 526971
• Device Lot Number: 01BT62263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• 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: 76535384 / LOT: 01BT62033.
• Patient Age: 54 YR
• Patient Sex: Female