MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123144
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a revision surgery where a device was explanted happened on (b)(6) 2021 due to metallosis.
Additional Manufacturer Narrative
It was reported that 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.Currently, the only lot number provided was ¿52m4 76131026¿ for the bhr cup.This is not a valid lot number.Until further information is received, the lot numbers for both parts in this investigation will be considered unknown.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part numbers provided for a bhr cup and bhr head in search of complaints involving metallosis throughout the lifetime of the product.Similar complaints have been identified.However, as bhr systems of this size are 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.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.Smith and nephew has not received the device and/or 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.
Additional Manufacturer Narrative
Section b4 was updated due to new information received.
Event or Problem Description
It was reported that, after a tha patient underwent a revision surgery on (b)(6) 2021 due to metallosis.Cup and head were explanted and an extensive washing was performed.Patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision, both the acetabular cup and femoral head were explanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Currently, the only lot number provided was ¿52m4 76131026¿ for the bhr cup.This is not a valid lot number.Until further information is received, the lot numbers for both parts in this investigation will be considered unknown.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the historical complaints data for the acetabular cup and the femoral head was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Regarding the acetabular cup, other similar complaints have been identified for this part number and the reported failure mode in this timeframe, however, as the device is no longer sold, no action is to be taken.Regarding the femoral head, no other similar complaints have been identified for this part number and the reported failure mode in this timeframe.As no device 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.The devices used in treatment have been phased out from the market and as a result there is no live risk management file to review.The available medical documents were reviewed.With the limited information provided the clinical root cause of the ¿reported effusion and intraoperative findings of ¿metallosis¿ cannot be confirmed but based on the pre-revision image, the positioning of the shell and the head could not be ruled out as contributing factors.Without prior imaging or implantation notes, migration of the components cannot be confirmed but is possibly based on their pre-revision orientation.It cannot be concluded the reported clinical reactions are associated with a mal performance of the implant.The patient impact beyond the revision and expected post-operative convalescence period cannot be determined.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: FEMORAL HEAD 44MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11476431
• Report Number: 3005975929-2021-00146
• Device Sequence Number: 3725258
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 3596010552419
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74123144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/31/2021; 10/28/2021; 02/09/2022
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/14/2021; 11/07/2021; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown