MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 11/07/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2009, it was noticed that the neck of the femoral stem was worn out, hence the system needed to be removed.A revision surgery was performed on (b)(6) 2023 to address this event, explanting all the system.Current health status of patient is unknown.

Manufacturer Narrative

The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the femoral stem.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the requested supporting clinical documentation had not been provided.The provided photos of the stem were reviewed and appears to show an scratched and damaged neck of the femoral stem.However, it is unknown if this was caused during the removal of the implant.It is noted the time in vivo was 14 years.The patient impact was the reported revision.No further clinical assessment is warranted at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions review could not be performed.However, a review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include irregular implant interaction, abnormal motion over time or patient condition.Based on this investigation, the need for corrective action is not indicated.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 for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H6: medical device problem code section h3, h6:the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the femoral stem.Therefore, no investigation is deemed for the other devices.The associated device was returned and evaluated.The visual inspection of the explanted stem revealed scratches, deformation of the head and bone cement still on the explant.The explant shows signs of wear.This inspection was conducted by naked eye.A lab analysis performed on the device revealed wear deformation and fracture on the neck and taper, possibly from friction between the tapered section of the femoral head which it engages, having a loose connection and moving.Also, there is a pronounced notch worn into the neck below the taper which could possibly be from a loosened taper interface and/or contacting the outer edge of an acetabular cup.There is a deformation of the material along the top edge of the tapered section that could have been formed by movement of the femoral head from a loose connection or possibly from mallet strikes during extraction.From the visual observations and information provided, no conclusions can be made as to what initiated the wear on the stem.Therefore, factors that could contribute to the reported event include friction, excessive forces or joint tightness.The clinical/medical investigation stated that the provided photos of the stem appear to show a scratched and damaged neck of the femoral stem.However, it is unknown if this was caused during the removal of the implant.It is noted the time in vivo was 14 years.The patient impact was the reported revision.No further clinical assessment is warranted at this time.A review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions review could not be performed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

D11: concomitant medical products and therapy dates section h3, h6: the associated devices were returned and evaluated.The visual inspection of the explanted stem revealed scratches, deformation of the head and bone cement still on the explant.The explant shows signs of wear.This inspection was conducted by naked eye.A lab analysis performed on the devices revealed wear deformation and fracture on the neck and taper of the stem, possibly from friction between the tapered section of the femoral head which it engages, having a loose connection and moving.Also, there is a pronounced notch worn into the neck below the taper which could possibly be from a loosened taper interface and/or contacting the outer edge of an acetabular cup.There is a deformation of the material along the top edge of the tapered section that could have been formed by movement of the femoral head from a loose connection or possibly from mallet strikes during extraction.In addition, the position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.Material loss was measured on the internal taper of the sleeve.Based on historic wear data, after 14.7 years in vivo, the measured combined linear wear is in line with the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.From the visual observations and information provided, no conclusions can be made as to what initiated the wear on the components.Therefore, factors that could contribute to the reported event include friction, excessive forces or joint tightness.The clinical/medical investigation stated that the provided photos of the stem appear to show a scratched and damaged neck of the femoral stem.However, it is unknown if this was caused during the removal of the implant.It is noted the time in vivo was 14 years.The patient impact was the reported revision.No further clinical assessment is warranted at this time.A review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.Devices' specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions review could not be performed.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• Type of Device: 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: 18209538
• MDR Text Key: 329017718
• Report Number: 3005975929-2023-00160
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 60MM W/ IMPTR, LOT#:36488; BHR MODULAR HEAD 54MM
• Patient Outcome(s): Required Intervention; Hospitalization; Other