MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Vision (2139); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 01/08/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pain, elevated metal ion levels, metallosis, pseudotumours, osteophytes, vision loss, reduced sexual activity, inability to sit or stand in one position for very long, loss of mobility and strength.

Manufacturer Narrative

It was reported that left hip surgery was performed due to to pain, elevated metal ion levels, metallosis, pseudotumours, osteophytes, vision loss, reduced sexual activity, inability to sit or stand in one position for very long, loss of mobility and strength.As of today, device return and additional information has been requested for this complaint but has not become available.Since no device part & lot details were received for investigation, no thorough manufacturing record review can be performed.The available medical documents were reviewed.According to the provided revision report, the patient had hip pain, elevated iron metal ions and an mri showed 2 cystic/pseudotumor-looking changes in the trochanteric and the iliac bursa area.During the revision, a brownish trochanteric bursa, a thinned and frayed gluteus medius, femoral neck osteophytes, well fixed and relatively well positioned cup, a thin anterior wall and slightly compromised soft medial wall were noted.A review of the implantation and revision report did not indicate any clear findings that could explain or have contributed to the reported reasons for the revision.No additional information on the reported elevated iron levels was provided.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip surgery was performed due to pain, elevated metal ion levels, metallosis, pseudotumours, osteophytes, vision loss, reduced sexual activity, inability to sit or stand in one position for very long, loss of mobility and strength.During revision, the bhr cup and the bhr head were removed.As of today, device return and additional information has been requested for this complaint but has 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.The available medical documents were reviewed.According to the provided revision report, the patient had hip pain, elevated iron metal ions and an mri showed 2 cystic/pseudotumor-looking changes in the trochanteric and the iliac bursa area.During the revision, a brownish trochanteric bursa, a thinned and frayed gluteus medius, femoral neck osteophytes, well fixed and relatively well positioned cup, a thin anterior wall and slightly compromised soft medial wall were noted.A review of the implantation and revision report did not indicate any clear findings that could explain or have contributed to the reported reasons for the revision.No additional information on the reported elevated iron levels was provided.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the bhr cup and head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head and cup 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 head.Similar complaints have been identified for the cup 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.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.No further actions are required at this time.The available medical documents were reviewed.The reported intraoperative findings of pseudotumor and elevated metal ion levels may be consistent with findings associated with metal debris.The root cause of the reported clinical symptoms cannot be confirmed, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient¿s claim of vision problems due to cobalt toxicity cannot be concluded, as he was diagnosed with age-related cataracts by an ophthalmologist.The patient impact beyond the revision and associated pain 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.

Manufacturer Narrative

It was reported that left 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.The 46mm bhr resurfacing are no longer sold by smith & nephew.A review of the 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.Similar complaints have been identified for the cup and head and this failure will continue to be monitored.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the 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.The available medical documents were reviewed.The reported intraoperative findings of pseudotumor and elevated metal ion levels may be consistent with findings associated with metal debris.The root cause of the reported clinical symptoms cannot be confirmed, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient¿s claim of vision problems due to cobalt toxicity cannot be concluded, as he was diagnosed age-related cataracts by an ophthalmologist.The patient impact beyond the revision and associated pain cannot be determined.The patient is reported to be doing well.However 14 months post-revision, the patient¿s bloodwork was repeated, and his cobalt level was higher than the pre-revision level.It¿s unknown if there are other sources of cobalt in the patient.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.

• Brand Name: ACETLR CUP HAP 52MM 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 7353102
• MDR Text Key: 102903135
• Report Number: 3005975929-2018-00108
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 74120152
• Device Lot Number: 10CW25958
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4121146/RESURFACING FEMORAL HEAD 46MM/UNKNOWN .; 74121146 RESURF FEM HEAD 46MM 10DW26921.; FEMORAL HEAD 46MM 74121146 LOT 10DW26921.; FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR