MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122546

Device Problems Corroded (1131); Material Discolored (1170); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 06/14/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain.Operative notes reportedly noted metallosis, corrosion, brown discoloration, a pseudotumor and elevated cobalt and chromium levels.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, metallosis, corrosion, brown discoloration, pseudotumor and elevated cobalt and chromium levels.During the revision the hemi head and modular sleeve were removed.Bhr cup and femoral stem remain implanted.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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient developed pain and had moderately elevated cobalt and chromium levels.No reports related to the blood metal ion levels were provided.During revision, upon incision the deep fascia a pseudotumor, described as cystic lesion with brownish discoloration and mild hypertrophy of the tissue and a pseudotumor emanating from the posterior aspect of the hip were noted.There was evidence of corrosion at the head-neck junction.The cup and stem were left in-vivo and had good position and stability.Without x-rays to be analysed further investigation on the underlying cause for the reported issues cannot be performed.It was also noted that a dual mobility liner and femoral head (manufacturer unknown) were used with the bhr cup in this revision event.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information "do not mix components from other manufacturers." additionally, these instructions also state under its warnings & precautions, ".If the bhr resurfacing head must be revised to a total hip arthroplasty, the acetabular shell should also be revised, even if well fixed." 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 hip revision surgery was performed due to pain.During surgery, the hemi head and the modular sleeve were removed.It was also noted that dual mobility polyethylene outer femoral head component with 46 mm outer diameter femoral head articulating (all stryker products) were implanted at the time of revision, alongside the remaining bhr cup.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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.It was reported that a right hip revision surgery was performed 9 years post tha, due to pain.In the operative note, surgeon describes metallosis, corrosion, brown discoloration, a pseudotumor and elevated cobalt and chromium levels.During a 5/2/2017 office visit cobalt and chromium levels were noted as 3.7 and 2.0 respectively, however no units of measure were given.The pathology report for a right pseudotumor, describes chronic inflammation and fine black metallic debris, consistent with periprosthetic metallosis and metalinduced synovitis.The revision was completed using a stryker dual mobility cup, impacted onto the retained femoral component.Although cobalt and chromium levels were reported as 3.7 and 2.0 respectively, no units of measure were given nor was a laboratory report provided.The reported pain and intraoperative findings of adverse tissue reaction and inflammation are consistent with findings associated with metallosis, however, the root cause cannot be determined nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.It was also noted that dual mobility polyethylene outer femoral head component with 46 mm outer diameter femoral head articulating (all stryker products) were implanted at the time of revision, alongside the remaining bhr cup.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿do not mix components from other manufacturers.¿ 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: HEMI HEAD 46MM
• 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: 7479426
• MDR Text Key: 107099593
• Report Number: 3005975929-2018-00139
• 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
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08EW17159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71357105/ANTHOLOGY HO POR PL HA SZ 5/08FM01613A; 74120154/ACETLR CUP HAP 54MM W/ IMPTR/089562; 74222300/MODULAR SLEEVE +4MM 12/14/07LW14963; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR