MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120148

Device Problems Biocompatibility (2886); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 06/24/2014

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a birmingham hip modular head system had been implanted on the patient¿s right hip on 03-dec-2008, the patient suffered from metal debris infiltration in the hip joint, surrounding tissue and the bloodstream.The issue resulted in a catastrophic failure of the right hip, which led to 2 revision surgeries to repair the extensive damage of the pelvis.The patient's current health status is unknown.

Manufacturer Narrative

D10, h3, h6: it was reported that two right hip revision surgeries were performed due to metal debris infiltration in the hip joint, surrounding tissue and the bloodstream.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without definitive batch numbers, a complete review of the historical complaints data cannot be performed for the devices concerned.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the hemi head.No other similar complaints were identified for the modular sleeve.However, as the devices are no longer sold, no action is to be taken.Other similar complaints were identified for the acetabular cup and this will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the ifus 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.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (metal debris infiltration in the hip joint, surrounding tissue and the bloodstream) 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 confirm or 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

Additional information: b6 corrected data: a2, b3, b5, e1, g2.

Event Description

It was reported that, after a birmingham hip modular head system had been implanted on the patient¿s right hip on (b)(6) 2008, the patient suffered from metal debris infiltration in the hip joint, surrounding tissue and the bloodstream.The ion levels on (b)(6) 2014 were cobalt 52,2 ug/l and chromium 62,9 ug/l, and on (b)(6) 2023 they were cobalt 59,7 ng/ml and chromium 31,9 ng/ml.The issue resulted in a catastrophic failure of the right hip, which led to 2 revision surgeries to repair the extensive damage of the pelvis.The patient's current health status is unknown.

Manufacturer Narrative

H10.Additional information in d4 (lot number and expiration date).H11.Corrected information in h6 (health effect - clinical code, health effect - impact code, and medical device problem code).

Event Description

It was reported that, after a birmingham hip modular head system had been implanted on the patient¿s right hip on (b)(6) 2008, the patient suffered from metal debris infiltration in the hip joint, surrounding tissue and the bloodstream.The ion levels on (b)(6) 2014 were cobalt 52,2 ug/l and chromium 62,9 ug/l, and on (b)(6) 2021 they were cobalt 59,7 ng/ml and chromium 31,9 ng/ml.Due to this, the patient underwent a revision surgery on june 2021 in which it was noticed that the acetabular cup was loose, so it was replaced.Current health status of the patient is unknown.

Manufacturer Narrative

Additional information: a4, d6b, e1 corrected data: b5, b6, b7, d1, d2, d4 (catalog number and unique identifier (udi) #), d10, g3/g4 (pma/510(k)number), h6 (health effect - clinical code), for h10: the reference previously provided (3005975929-3/10/15-001) corresponds to the concomitant devices 74122542 hemi head 42mm and 74222400 modular sleeve +8mm 12/14.

Manufacturer Narrative

Section h3, h6: it was reported that a right hip revision surgery was performed due to metal debris infiltration and high ion levels.Loosening of the acetabular cup was noted intra-operatively.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.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.This will continue to be monitored via routine trending, however it should be noted that these devices, as well as the sleeve, are no longer sold.Without a valid batch number, a complete review of the historical complaints data cannot be performed for the sleeve.In the absence of the actual devices, the production records were reviewed for the head and the cup reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.As a non-valid batch number was provided for the sleeve involved in the investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.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 morbid obesity had on her pain and clinical status.With the limited information provided the clinical root cause of the reported mechanical loosening of the acetabular component and increased metal ions, prior to the first revision, cannot be confirmed.It should be noted, the mix manufacturer construct of the implants prior to dislocation, closed reduction and subsequent second revision cannot be ruled out as possible contributing factors to the patient¿s dislocation and subsequent revision.Hematoma is a known complication of surgery, and it is likely related to the revision surgery and not the implant.Without the implantation and pre-revision x-rays, the initial acetabular placement cannot be determined.The reported protrusion of the acetabular component may be consistent with the continuation of the fracture line into the posterior column, and pelvic discontinuity.However, the clinical root cause of the fracture line, and pelvic discontinuity cannot be confirmed.The patient impact beyond the reported revision cannot be determined with the information provided.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.

Manufacturer Narrative

H9: the concomitant device 74120148 acetlr cup hap 48mm w/ imptr was also subject to an action that was reported to fda.Fda recall z-2746-2015.H3, h6.It was reported that two right hip revision surgeries were performed due to metal debris infiltration in the hip joint, surrounding tissue and the bloodstream.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without definitive batch numbers, a complete review of the historical complaints data cannot be performed for the devices concerned.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the hemi head and the cup.No other similar complaints were identified for the modular sleeve.This will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.As no device batch numbers were provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the ifus 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 morbid obesity had on her pain and clinical status.With the limited information provided the clinical root cause of the reported mechanical loosening of the acetabular component and increased metal ions, prior to the first revision, cannot be confirmed.It should be noted it cannot be determined from the information provided what implants were implanted at the time of the second revision.Hematoma is a known complication of surgery, and it is likely related to the revision surgery and not the implant.Without the implantation and pre-revision x-rays, the initial acetabular placement cannot be determined.The reported protrusio of the acetabular component may be consistent with the continuation of the fracture line into the posterior column, and pelvic discontinuity.However, the clinical root cause of the fracture line, and pelvic discontinuity cannot be confirmed.The patient impact beyond the reported revision cannot be determined with the 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.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to metal debris infiltration and high ion levels.Loosening of the acetabular cup was noted intra-operatively.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.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.This will continue to be monitored via routine trending, however it should be noted that these devices, as well as the sleeve, are no longer sold.Without a valid batch number, a complete review of the historical complaints data or a device history record review cannot be performed for the sleeve.In the absence of the actual devices, the production records were reviewed for the head and the cup 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.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 morbid obesity had on her pain and clinical status.With the limited information provided the clinical root cause of the reported mechanical loosening of the acetabular component and increased metal ions, prior to the first revision, cannot be confirmed.It should be noted, the mix manufacturer construct of the implants prior to dislocation, closed reduction and subsequent second revision cannot be ruled out as possible contributing factors to the patient¿s dislocation and subsequent revision.Hematoma is a known complication of surgery, and it is likely related to the revision surgery and not the implant.Without the implantation and pre-revision x-rays, the initial acetabular placement cannot be determined.The reported protrusion of the acetabular component may be consistent with the continuation of the fracture line into the posterior column, and pelvic discontinuity.However, the clinical root cause of the fracture line, and pelvic discontinuity cannot be confirmed.The patient impact beyond the reported revision cannot be determined with the information provided.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: ACETLR CUP HAP 48MM 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: 15674249
• MDR Text Key: 302427351
• Report Number: 3005975929-2022-00481
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 3596010502551
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Catalogue Number: 74120148
• Device Lot Number: 86655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• 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: A
• Removal/Correction Number: Z-2746-2015
• Patient Sequence Number: 1
• Treatment: 71306612 / LOT# 08KM21856; 74122542 / LOT# 08EW17100; 74122542//HEMI HEAD 42MM; 74222400 / LOT# 07LW14979; 74222400//MODULAR SLEEVE +8MM 12/14; PN: 74120148 / LOT: UNKNOWN; PN: 74222400 / LOT: UNKNOWN; UNKNOWN SYNERGY HIP STEM UNCEMENTED
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 118 KG