MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 08/10/2022

Event Type  Injury  

Event Description

Us legal: it is reported that, after bhr-tha on (b)(6) 2010, the plaintiff has suffered from metallosis and multi-system reaction which has caused him pain and mental anguish.Plaintiff underwent revision surgery on an unknown date.The patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

It was reported that revision surgery was performed on the patient¿s hip.As of today, the devices used in treatment have been requested but have not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling and ifu review could not be performed.A risk management review was performed for the cup.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A risk management review could not be performed for the hemi head as it has been phased out the market, therefore there is no live risk management file to review for the head.The available medical information was reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain and metal debris) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Without return of the actual devices or further information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

Additional information: b6 (metal ion levels in blood added).Corrected data: b3, h6 (health effect - clinical code and health effect - impact code).

Manufacturer Narrative

It was reported that after bhr total hip arthroplasty, the plaintiff has suffered from metallosis and multi-system reaction which has caused him pain and mental anguish.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's current instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the bhr acetabular cup.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.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain and metal debris) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Based on the information provided we cannot further investigate the reported complaint, our investigation remains inconclusive, and 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.

Manufacturer Narrative

H3, h6: it is reported that right hip revision surgery was performed due to metallosis and a multi-system reaction, which caused the patient pain and mental anguish.A blood test result revealed a chromium level in serum of 4 ng/ml and a cobalt level in serum of 10.6 ng/ml.As of today, the implanted devices, all of which were used in treatment, have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or escalation actions review could not be performed.If more information is received, these tasks will be reevaluated.A review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review found that 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.With the limited information provided the clinical root cause of the reported elevated cobalt and reported pain, metallosis and multi-system reaction cannot be confirmed.It cannot be concluded the reported events/clinical reactions were associated with a mal-performance of the implant or an implant failure.The patient impact beyond the reported pain, revision and post operative convalescence period cannot be determined with the limited information provided.Based on the information provided we cannot further investigate the reported complaint, our investigation remains inconclusive, and 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.

Event Description

It is reported that, after a right bhr-tha had been performed on (b)(6) 2010, the patient has suffered from metallosis and multi-system reaction which has caused him pain and mental anguish.A blood test result performed on (b)(6) 2022 revealed a chromium level in serum of 4 ng/ml and a cobalt level in serum of 10.6 ng/ml.The patient underwent revision surgery on (b)(6) 2023.During the revision, the cup was well fixed with corrosion at the margins.There was deficient bone in the posterior wall.Also, there was corrosion and black material on the trunnion.A large amount of scar had to be removed from above and below the trunnion to allow mobilization.The patient's current health status is unknown.

Manufacturer Narrative

Additional information: b5-describe event or problem.B6-relevant tests/laboratory data.

Manufacturer Narrative

H3, h6: it is reported that right hip revision surgery was performed due to metallosis and a multi-system reaction, which caused the patient pain and mental anguish.A blood test result revealed a chromium level in serum of 4 ng/ml and a cobalt level in serum of 10.6 ng/ml.As of today, the implanted devices, all of which were used in treatment, have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or escalation actions review could not be performed.If more information is received, these tasks will be reevaluated.A review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review found that 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.Although the reported pain, elevated cobalt, necrosis and corrosion may be consistent with the reported trunnionosis, with the information provided, the clinical root cause of the reported elevated cobalt and reported pain, metallosis and multi-system reaction cannot be confirmed.It cannot be concluded the reported events/clinical reactions were associated with a mal performance of the implant.The patient impact beyond the reported pain, revision and post operative convalescence period cannot be determined with the information provided.Four-weeks post-operative cobalt and chromium were 4.1 and 1.7 ng/ml respectively.Based on the information provided we cannot further investigate the reported complaint, our investigation remains inconclusive, and 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.

Manufacturer Narrative

H3, h6: it is reported that right hip revision surgery was performed due to metallosis and a multi-system reaction, which caused the patient pain and mental anguish.A blood test result revealed a chromium level in serum of 4 ng/ml and a cobalt level in serum of 10.6 ng/ml.As of today, the implanted devices, all of which were used in treatment, have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or escalation actions review could not be performed.If more information is received, these tasks will be reevaluated.A review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review found that 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.Although the reported pain, elevated cobalt, necrosis and corrosion may be consistent with the reported trunnionosis, with the information provided, the clinical root cause of the reported elevated cobalt and reported pain, metallosis and multi-system reaction cannot be confirmed.It cannot be concluded the reported events/clinical reactions were associated with a mal performance of the implant.The patient impact beyond the reported pain, revision and post operative convalescence period cannot be determined with the information provided.Four-weeks post-operative cobalt and chromium were 4.1 and 1.7 ng/ml respectively.Based on the information provided we cannot further investigate the reported complaint, our investigation remains inconclusive, and 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.Additional information: a2, a4, b7, d6b, d10.Corrected data: e1 (reporter's name), g2, h6 (health effect - clinical code).

Manufacturer Narrative

H10- additional information.D4- unique identifier (udi) #, expiration date.D10- concomitant medical products.H4- device manufacture date h11- corrected data.B5- describe event or problem.D4- catalog number, lot number.

Event Description

It was reported that, after a right bhr-tha had been performed on (b)(6) 2010, the patient has suffered from metallosis and multi-system reaction which has caused him pain and mental anguish.A blood test result performed on (b)(6) 2022 revealed a chromium level in serum of 4 ng/ml and a cobalt level in serum of 10.6 ng/ml, for which the patient underwent revision surgery on (b)(6) 2023.During this procedure, the femoral stem was found to be well-fixed.Corrosion and black material was noted on the trunnion, which was cleaned and subsequently found to be undamaged.The acetabular cup, hemi-head and modular sleeve were removed and replaced with a competitor's construct (zimmer-biomet).The patient was discharged to the recovery room in stable condition.

Manufacturer Narrative

Corrected data: b6 (test results).

• Brand Name: ACETLR CUP HAP 58MM 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: 13896773
• MDR Text Key: 288382102
• Report Number: 3005975929-2022-00082
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 74120158
• Device Lot Number: 081682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2007
• 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: ANTLGY SZ 9 STM: 71357009, 08LM09718A; HM HD 50MM: 74122550, 08HW18259; MLR SLV12/14: 74222200, 08JW19031; UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG