MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120160

Device Problem Compatibility Problem (2960)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that a revision surgery was performed on (b)(6) 2020.The revision surgery was performed due to implant deterioration and streaming of cobalt and chromium ions on the patient bloodstream.

Manufacturer Narrative

A bhr head (74121154, 73062 sn (b)(6)) which was used for treatment was received for investigation.A product evaluation was performed, visual inspection noted a wear patch and discolouration around the wear patch on the bearing surface.Wear analysis was performed on the bhr head to review linear wear on the bearing surface.The wear image identified a wear patch on the bearing surface of the head.The maximum linear wear for the bhr head was 33.2 ¿m.Based on historic wear data, after 13.3 years in vivo, the measured linear wear on the head is higher than the expected head wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.A review of the product history was performed, complaint history for the bhr cup and bhr head 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 head and bhr cup.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 instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed and concluded.Without the supporting operative reports/ lab results and/or imaging, the root cause of the reported ¿streaming of cobalt and chromium in the blood and synovitis noted on the pathology report cannot be confirmed and it cannot be concluded that the reported clinical reactions was associated with a mal-performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the available information we are unable to find a root cause.If additional information become available in the future, this case will be reopened.No preventive or corrective action has been initiated as a result of this investigation.The bhr head will be retained at s+n leamington spa and is available for return if requested.

Manufacturer Narrative

Section b6 were updated due to new information received.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.A bhr head (74121154, 73062 sn (b)(6)) which was used for treatment was received for investigation.A product evaluation was performed, visual inspection noted a wear patch and discolouration around the wear patch on the bearing surface.Wear analysis was performed on the bhr head to review linear wear on the bearing surface.The wear image identified a wear patch on the bearing surface of the head.The maximum linear wear for the bhr head was 33.2 m.Based on historic wear data, after 13.3 years in vivo, the measured linear wear on the head is higher than the expected head wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.A review of the historical complaints data for the femoral head and the acetabular cup was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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.No other similar complaints were identified to involve this batch of femoral heads, other similar complaints have been identified for its part number and reported failure mode in this timeframe, and this failure will continue to be monitored.A similar complaint was identified to involve this batch of acetabular cups and other similar complaints have been identified for its part number and the reported failure mode in this timeframe, and this failure will continue to be monitored.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.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible, no further escalation actions required.The available medical documents were reviewed and concluded.With the information provided, the clinical root cause of the reported ¿streaming of cobalt and chromium in the blood and synovitis¿ noted on the pathology report cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-operative convalescence period cannot be determined.Based on the information provided and product evaluation of the returned device, we can confirm this complaint; yet a definitive root cause cannot be determined.Based on the information provided, factors known to contribute to the alleged fault include excessive physical activity levels and loosening of the components, increasing the production of wear particles, accelerating damage to the bone.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.The bhr head will be retained and is available for return if requested.Internal reference number: (b)(4).

Manufacturer Narrative

It was reported that right hip revision surgery was performed.A bhr head (74121154, 73062, sn (b)(6) which was used for treatment was received for investigation.A product evaluation was performed, visual inspection noted a wear patch and discolouration around the wear patch on the bearing surface.Wear analysis was performed on the bhr head to review linear wear on the bearing surface.The wear image identified a wear patch on the bearing surface of the head.The maximum linear wear for the bhr head was 33.2 m.Based on historic wear data, after 13.3 years in vivo, the measured linear wear on the head is higher than the expected head wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.A review of the historical complaints data for the femoral head and the acetabular cup was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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.No other similar complaints were identified to involve this batch of femoral heads, other similar complaints have been identified for its part number and reported failure mode in this timeframe, and this failure will continue to be monitored.A similar complaint was identified to involve this batch of acetabular cups and other similar complaints have been identified for its part number and the reported failure mode in this timeframe, and this failure will continue to be monitored.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.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible, no further escalation actions required.The available medical documents were reviewed and concluded.With the information provided, the clinical root cause of the reported ¿streaming of cobalt and chromium in the blood and synovitis¿ noted on the pathology report cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-operative convalescence period cannot be determined.Based on the information provided and product evaluation of the returned device, we can confirm this complaint; yet a definitive root cause cannot be determined.Based on the information provided, factors known to contribute to the alleged fault include excessive physical activity levels and loosening of the components, increasing the production of wear particles, accelerating damage to the bone.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.The bhr head will be retained and is available for return if requested.Internal reference number: (b)(4).

• Brand Name: ACETLR CUP HAP 60MM W/ IMPTR
• 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: 10910358
• MDR Text Key: 218503870
• Report Number: 3005975929-2020-00469
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120160
• Device Catalogue Number: 74120160
• Device Lot Number: 70570
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male