MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74122550

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Metal Related Pathology (4530)

Event Date 01/15/2016

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip due to unknown reasons.The cup, head and sleeve were explanted.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.Without definitive part/lot numbers a complaint history review cannot be performed for the sleeve and stem.Without definitive lot numbers a complete complaint history review cannot be performed for the bhr cup and hemi head involved.A review of the complaint history review was performed using the part numbers throughout the lifetime of the product.The 56mm bhr cup and 50mm hemi head devices are noted in other complaints.However, without a reason for report, it cannot be confirmed whether any of the complaints share similarities.Additionally, as the hemi head is no longer sold, no action is to be taken.As no device part and batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without the details of the devices, medical details of the reported issue, failure modes and reason for revision involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available at a later time, the task will be reopened and completed.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H3, h6: it was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup, hemi head and stem.Similar complaints have been identified for the modular sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided, of the elevated metal ion levels, osteolysis and black corrosive wear may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with implant failure.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 50MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10382021
• MDR Text Key: 202108599
• Report Number: 3005975929-2020-00283
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 00885556071205
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74122550
• Device Catalogue Number: 74122550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention