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

Catalog Number 74120152

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that revision was performed.

Event Description

It has not been possible to confirm whether the revision surgery occurred as planned.

Manufacturer Narrative

This complaint has been reopened following receipt of additional medical information.As of today, device return and additional information has been requested for this complaint but has not become available.The most recently supplied information does not report a revision for the right hip involved in this complaint.In the absence of the actual devices, the production records were reviewed for the devices identified above.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The updated supplied medical information was reviewed for this bilateral metal on metal patient.As no blood metal ion concentrations were provided after the left metal-on-metal device explanation (b)(4), it remains unknown which device contributed to the reported levels.The provided x-rays showed an adequate implant position.The mris indicated that there were no adverse findings.No revision was reported for the right hip (b)(4).In previous investigation of this event, other medical reports were also reviewed.According to the provided admission report 7 ((b)(4), left) and 8 ((b)(4), right) years after the implantation, the patient was suspected to have metallosis and had pathological high cobalt concentration (24 g/l).According to the complaint description, an mri was performed at that time and showed signs of increased metal residues and osteolysis in the left hip.Corresponding reports to the reported findings were not provided.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.Correct information is 75002073/polarstem stemstdti/ha4non-cem/b0802706 instead of femora lstem, # 75100467, lot # b0802706.

• 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: 6380179
• MDR Text Key: 69143548
• Report Number: 3005975929-2017-00048
• 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,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 08CW16259
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2017
• Patient Sequence Number: 1
• Treatment: 75002073/POLARSTEM STEMSTDTI/HA4NON-CEM/B0802706 /; FEMORAL STEM, # 75100467, LOT # B0802706; MODULAR HEAD, # 74121346, LOT # 61629; FEMORAL STEM, # 75100467, LOT # B0802706; MODULAR HEAD, # 74121346, LOT # 61629
• Patient Outcome(s): Hospitalization; Required Intervention