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

Catalog Number 74120150

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Toxicity (2333)

Event Date 04/12/2017

Event Type  Injury  

Event Description

Left hip revision surgery was performed due to elevated levels of cobalt and chromium, pseudotumour, plus aseptic loosening of acetabular components.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the acetabular cup, hemi head and modular sleeve were removed.The anthology stem remained implanted.As of today, the implanted devices, all of which were used in treatment and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup, hemi head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s comorbidities had on her pain and clinical status.The reported pain, elevated metal ions, along with intraoperative findings of metal staining, necrotic tissue and extensive corrosion on the trunnion may be consistent with the resulting pseudotumor from trunnionosis.However, 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.The patient impact beyond the pain, revision, and expected transient post-op convalescence period 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.

• Brand Name: BHR ACETABULAR CUP 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora housa; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8063148
• MDR Text Key: 126917229
• Report Number: 3005975929-2018-00437
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 090203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356006 FEMORAL STEM 08CM17522; 74122542 HEMI HEAD 08CW16083; 74222200 MODULAR SLEEVE 08BW15652; 71356006 FEMORAL STEM 08CM17522; 74122542 HEMI HEAD 08CW16083; 74222200 MODULAR SLEEVE 08BW15652
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR