MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Arthralgia (2355); Metal Related Pathology (4530)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2020.The revision surgery was performed due to pain, and elevated chromium and cobalt levels from failed right hip resurfacing.Mri confirmed a fluid collection with extensive bursal tissue reaction.Among the intraoperative findings were: metallosis, including metallic staining consistent with metal on metal wear and resulting adverse metal reaction causing a failed right resurfacing arthroplasty.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right 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.As no device details have been made available for this complaint, no documentation review could be performed.However, all released devices would have met manufacturing specifications at the time of production.The available medical documents were reviewed.It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2020.The revision surgery was performed due to pain, and elevated chromium and cobalt levels from failed right hip resurfacing.Mri confirmed a fluid collection with extensive bursal tissue reaction.Among the intraoperative findings were: metallosis, including metallic staining consistent with metal on metal wear and resulting adverse metal reaction causing a failed right resurfacing arthroplasty.The patient outcome is unknown.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 right 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.A review of the complaint history for the bhr head and bhr cup, hemi head and modular sleeve 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.Similar complaints have been identified for the bhr cup.However, as bhr systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product's 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 result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The reported pain, elevated metal ions and operative findings of slight metallic staining and clear effusion may be consistent with findings associated with metallosis.However, the root cause of the reported clinical reactions 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 pain, revision, and expected transient post-op convalescence period cannot be determined.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.

Event Description

It was reported that, after undergoing right hip resurfacing (bhr) on (b)(6) 2011 due to osteoarthritis, the patient suffered from metallosis.Elevated metal levels (cobalt and chromium) were confirmed in conjunction with mri findings that revealed small fluid collection with no extensive bursal tissue reaction.Slight metallic staining of the joint was noted.Even though the resurfacing cup was well-fixed, it was explanted and replaced with a competitor¿s tha system (stryker).Patient¿s current health status is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metallosis, elevated metal ion levels and a small fluid collection.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.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.Prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; it was confirmed that the listed batch was manufactured before corrective action implementation.No further escalation actions are required.A review of the complaint history for the devices performed using batch numbers in search of similar recurring reports for the products during their lifetimes.One similar complaint was identified for the bhr head.Similar complaints have been received in the past year involving both parts and the same failure mode.This will continue to be monitored via routine trending, however it should be noted that devices of this size are no longer sold.The supplied medical documentation was evaluated and concluded that the reported pain, elevated metal ions and operative findings of slight metallic staining and clear effusion may be consistent with findings associated with metallosis.However, the root cause of the reported clinical reactions 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 pain, revision, and expected transient post-op convalescence period cannot be determined.However, six weeks post revision the patient's hip was functioning well overall.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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: RESURFACING FEMORAL HEAD 46MM
• 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: 11023277
• MDR Text Key: 222012154
• Report Number: 3005975929-2020-00506
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 3596010502780
• 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: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2015
• Device Catalogue Number: 74121146
• Device Lot Number: 10KW30179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: ACTLR CP 52MM(PN:74120152,LN:092551)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 100 KG