MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120154

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Injury (2348)

Event Date 05/08/2015

Event Type  Injury  

Event Description

It was reported that patient underwent left hip revision surgery due to failed left hip resurfacing, elevated level of cobalt and chromium, and cobalt and chromium toxicity.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to failed left hip resurfacing, elevated level of cobalt and chromium, and cobalt and chromium toxicity.During the revision both the bhr head and bhr cup were removed.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.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 had a vertically faced cup, grinding and squeaking, discomfort and elevated ion levels.During the revision, a small effusion in the capsule and some necrosis at the head/trunnion.A vertical cup position may cause the reported findings, such as grinding, pain and elevated metal ions and associated wear.However without x-rays the extent of the inclination cannot be assessed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, however the available information suggests a potential root cause of improper loading due to the vertical orientation of the bhr cup, although x-rays would be needed to confirm this.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

New info other relevant history& evice evaluated by mfr - attachment: [176473 summary.Pdf].

• Brand Name: ACETLR CUP HAP 54MM 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: 7188937
• MDR Text Key: 97279953
• Report Number: 3005975929-2018-00017
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Catalogue Number: 74120154
• Device Lot Number: 59504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4), LOT NUMBER 71381; (B)(4), UNKNOWN LOT NUMBER.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR