MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/28/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to device malfunction, pain, loss of mobility, elevated metal ion levels and user annoyance.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to device malfunction, pain, loss of mobility, elevated metal ion levels and user annoyance.During the revision the hemi head, modular sleeve and bhr cup were removed.The femoral stem remains 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.Per the left hip revision/conversion operative note the acetabular cup was ¿vertically placed¿ and a small amount of trunnionosis was noted with ¿a lot of metallosis in the tissue and a lot of fluid¿ inside the left hip synovium, of which culture swabs, fluid and tissue were taken.Intraoperatively there were ¿no signs of metallosis around the (acetabular) cup but there was significant wearing-out of the posterior wall, which was completely gone.There was superior erosion as well¿.The device was not returned and no supporting documentation or pathology report was provided to support the reported device malfunction, elevated metal ion levels or metallosis.Without radiological imaging to evaluate the primary acetabular cup position, unable to rule out the ¿vertically placed¿ cup position as a contributing factor, as vertical-positioning is prone to excessive wear, edge loading and possible early component failure.No ¿metallosis¿ was noted around the cup, just significant/complete erosion of the posterior wall.No supporting documentation or pathology report was provided to support the reported device malfunction, elevated metal ion levels or metallosis.The patient impact beyond the reported symptoms and l hip revision/tha 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.During the revision, the bhr cup, modular sleeve and hemi head were removed.The synergy 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.A 2017 x-ray showed the acetabular component in vertical position.The intraoperative report indicated metallosis in the tissue and a small amount of trunnionosis on the trunnion.The cup showed no signs of metallosis around the cup but there was significant wearing-out of the posterior wall.The cup was well-fixed but in a vertical position.There was a loss of the complete posterior wall and superior portion of the acetabulum.The vertically positioned cup cannot be ruled out as a contributing factor, as vertical-positioning is prone to excessive wear, edge loading and possible early component failure.The reported pain, elevated cobalt and chromium and intraoperative findings of trunnionosis and erosion are consistent with findings associated with metallosis.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause 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.However, based on the available information, a root cause of improper loading has been selected due to the vertical position of the cup.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.Additional information: relevant tests/laboratory data.

• Brand Name: ACETLR CUP HAP 56MM 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: 7346235
• MDR Text Key: 102705399
• Report Number: 3005975929-2018-00097
• 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: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 74120156
• Device Lot Number: 12EW37470
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2018
• Patient Sequence Number: 1
• Treatment: 71306614/SYN POR FEM COMP SZ 14/12JM16064; 74122550/HEMI HEAD 50MM/08MW20698; 74222100/MODULAR SLEEVE -4MM 12/14/10CW25953; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR