MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHORT MODULAR FEM NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED

Catalog Number UNKNOWN

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

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Injury (2348); Ambulation Difficulties (2544); Implant Pain (4561)

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

It was reported that 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.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A medical analysis noted that 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.It is unclear if the fall precipitated the event.Impact to the patient cannot be determined beyond the surgery and recovery.Based on this investigation, the need for corrective action is not indicated.The potential cause could include but is not limited to trauma injury.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.Case-2020-00010121-2.

Manufacturer Narrative

The device used in treatment was not returned for evaluation and the reported event could not be confirmed.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 at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The device reported initially was incorrect, the corrected device under this case is not the cause of any adverse event or malfunction.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SHORT MODULAR FEM NECK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED
• 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 ; 0447940038
• MDR Report Key: 10312788
• MDR Text Key: 200013851
• Report Number: 1020279-2020-03453
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• 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