MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Cardiomyopathy (1764); Congestive Heart Failure (1783); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Toxicity (2333); Injury (2348); Osteolysis (2377); Test Result (2695)

Event Date 05/19/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to severe pain, failed left hip resurfacing, tissue necrosis, osteolysis, pseudotumors, fluid around the hip, metal poisoning and metallosis, significantly elevated levels of cobalt and chromium, cobalt induced cardiomyopathy, and congestive heart failure.Findings noted a large amount of turbid, dark, metal-stained fluid; large encapsulated tissue throughout hip consistent with pseudotumor; and necrotic tissue.Cup implanted during original resurfacing (b)(6) 2006.Other parts during first revision to thr (b)(6) 2012.

Manufacturer Narrative

It was reported that the left hip revision surgery was performed.During the revision, the cup, head and the stem were removed.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 hemi head, modular sleeve, stem and acetabular 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 stem.Similar complaints have been identified for the hemi head and the modular sleeve however, as the device is no longer sold, no action is to be taken.Similar complaints have been identified for the acetabular cup.This 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.It was also confirmed that all devices were sterilised.The available medical documents were reviewed.Although, the osteolysis and metal stained synovium that was present may be consistent with findings associated with metal debris.The source of the infection which led to the second left hip, 2-stage revision, and the right hip femoral neck fracture also cannot be concluded.Without complete medical records, radiological images and/or the explanted components, the reported clinical symptoms cannot be confirmed, nor can it be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the multiple revisions and expected post-operative healing/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 the left hip revision surgery was performed.During the revision, the cup, head and the stem were removed.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 hemi head, modular sleeve, stem and acetabular 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 stem.Similar complaints have been identified for the hemi head and the modular sleeve however, as the device is no longer sold, no action is to be taken.Similar complaints have been identified for the acetabular cup.This 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.It was also confirmed that all devices were sterilised.The available medical documents were reviewed.Although, the osteolysis and metal stained synovium that was present may be consistent with findings associated with metal debris.The source of the infection which led to the second left hip, 2-stage revision, and the right hip femoral neck fracture also cannot be concluded.Without complete medical records, radiological images and/or the explanted components, the reported clinical symptoms cannot be confirmed, nor can it be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the multiple revisions and expected post-operative healing/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.

• Brand Name: BHR ACETABULAR CUP 52MM
• 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: 9080403
• MDR Text Key: 161798195
• Report Number: 3005975929-2019-00334
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 08KW19322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71357002 ANT SO POR PL HA SZ 2 07HM04885; 74120152 ACETLR CUP HAP 52MM W/ IMPTR 61977; 74222300 MOD SLEEVE +4MM 12/14 10CW25956; FEMORAL STEM, # 71357002, LOT # UNKNOWN; HEMI HEAD, # 74122546, LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention