MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74123148

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

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Metal Related Pathology (4530)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

It was reported that a revision surgery was performed on the patient left hip on (b)(6) 2019.The revision surgery was performed due to pain, limited mobility, and elevated metal ion levels.The cup was not explanted.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup 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 head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.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.The available medical documents were reviewed.Although increased metal ions were reported, neither the units of measure nor the lab reports were provided.It cannot be determined to what extent the patient¿s ¿radicular type pain¿ had on her reported pain and limited mobility.The revision document does not note findings consistent with metallosis.With the limited information provided, the clinical root cause of the reported pain, increased metal ion levels and limited mobility 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 a left hip bhr surgery was performed on (b)(6) 2010, the patient suffered from a fall and started to experience increasing pain in the left hip, as well as sensation of stiffness and numbness, also, the hip was not moving appropriately, so walking difficulty was experienced.On (b)(6) 2019 cobalt and chromium levels were noticed to be elevated.A revision surgery was performed on (b)(6) 2019, where the resurfacing femoral head was exchanged for a tha system.Current health status of the patient is unknown.

Manufacturer Narrative

Additional information: h6, h10.H3, h6: it was reported that a left hip revision surgery was performed due to pain, sensation of stiffness and numbness, walking difficulty, and cobalt and chromium levels were noticed to be elevated.As of today, the implanted head, which was used in treatment has not been returned for evaluation.The cup remains implanted and therefore cannot be tested.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the cup and the head, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The 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 historic 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 are required.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s ¿radicular type pain¿ had on her reported pain and limited mobility.The revision document does not note findings consistent with metallosis.With the limited information provided the clinical root cause of the reported pain, increased metal ion levels and limited mobility cannot be confirmed; however, the patients¿ history of falling, obesity, chronic low back pain, and radicular type pain cannot be ruled out as possible contributing factors to her pain and clinical status.It cannot be concluded that the reported events/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.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: FEMORAL HEAD 48MM
• 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: 11330372
• MDR Text Key: 232395495
• Report Number: 3005975929-2021-00090
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552426
• UDI-Public: 03596010552426
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2013
• Device Model Number: 74123148
• Device Catalogue Number: 74123148
• Device Lot Number: 08KW19657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2008
• 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
• Treatment: (B)(6) ACETABULAR CUP HAP SIZE 48/54
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 104 KG