MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE CER 28 HD 12/14 +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC

Model Number 71330280

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/05/2020

Event Type  Injury  

Event Description

It was reported that the patient presented a fall earlier in the year, with a completely symptom-free interval.After that, the patient had presented a crack sound in the left hip when he was tried to bend down or move.A revision was carried out, where it was possible to observe a fracture of the ceramic head with the destruction of the femoral neck.For this reason, a change of head, the femoral neck and the insert were necessary.The insert was removed because it's necessary to do it the change of head and femoral neck.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.The clinical/medical team concluded, this complaint from germany reports a revision was performed after a fall and cracking noise developed in the left hip.Surgery revealed a fracture of the ceramic head and destruction of the shaft cone.The stem, head and the inlay were changed out.Only the report that the surgery had been done was provided.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.It is unclear if the fall precipitated the event.Impact to the patient cannot be determined beyond the surgery and recovery.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.D4 part number corrected.

Manufacturer Narrative

The associated device was returned and evaluated.Visual inspection of the retrieved, shattered, 28mm ceramic femoral head revealed scratches and metal transfer (black markings) on the articulating surface and od taper, and radial scratches on the id female taper.The id radial scratches are typically indicative signs of strong fixation between the head and the stem interface, as designed.It is very likely that the shattering of the ceramic femoral head was caused at the time of the reported patient "fall" or at minimum propagated a fracture on the implant.The scratches and metal transfer on the articulating surface were more than likely caused after the femoral head shattered & contacted / articulated against the acetabular and/or femoral components.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that this complaint from germany reports a revision was performed after a fall and cracking noise developed in the left hip.Surgery revealed a fracture of the ceramic head and destruction of the shaft cone.The stem, head and the inlay were changed out.Only the report that the surgery had been done was provided.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.It is unclear if the fall precipitated the event.Impact to the patient cannot be determined beyond the surgery and recovery.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: BIOLOX FORTE CER 28 HD 12/14 +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
• 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: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10312782
• MDR Text Key: 200013913
• Report Number: 1020279-2020-03452
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556020838
• UDI-Public: 00885556020838
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71330280
• Device Catalogue Number: 526969
• Device Lot Number: 04AT77783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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: INSERT UNK PART NUMBER; INSERT UNK PART NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention