MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Injury (2348); Test Result (2695)

Event Date 06/16/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metal ion levels.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to elevated metal ion levels.During the revision the hemi head, modular sleeve and bhr cup were removed.The femoral stem remained 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 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.The provided laboratory reports dated approximately 2 months before the revision indicate that serum cobalt was high at 19 ng/ml (reference: 0-0.9, reference with metal on metal implant: <10)) and blood chromium was deemed abnormally high at 15 ng/ml (reference: 0-0.3).According to the provided revision report, the patient had no pre-operative signs of infection, high blood metal ions and pain.During the revision, a scarred capsule, large amount of effusion that did not appear of infection were noted.It was noted, that part of the medial wall was destroyed (with protrusion on x-rays) either due to the previous surgery or due to wear.Review of the provided implantation report did not report on acetabular protrusion or any inconsistencies related to the surgical technique that could explain the later revision.The relation between the reported findings and the high blood metal ions and pain cannot be further investigated.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.During the revision, the acetabular cup, hemi head & modular sleeve were removed.The stem remained 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.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.Intra-operatively there was a large amount of effusion that did not appear infected in nature.X-rays were taken intra-operatively, a large amount of leg length discrepancy had been resolved with a good offset and good cup position.The reported pain caused by degenerative changes, leg length discrepancy, large effusion along with increased metal ion levels were consistent with metallosis.The effusion intraoperatively was cultured and was negative after 5 days.The patient has a long standing history of avn in both hips and past left hip infection.The initial staph infection along with the long standing history of avn, and metallosis.However, without the supporting lab results, imaging and the analysis of the explanted components the source of reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 50MM
• 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: 7532625
• MDR Text Key: 108850710
• Report Number: 3005975929-2018-00173
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 03596010502568
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 089743
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71340111, LOT # 07HM13457.; HEMI HEAD, # 74122542, LOT # 08EW17102.; MODULAR SLEEVE, # 74222100, LOT # 08CW16009.; FEMORAL STEM, # 71340111, LOT # 07HM13457; HEMI HEAD, # 74122542, LOT # 08EW17102; MODULAR SLEEVE, # 74222100, LOT # 08CW16009
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR