MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Catalog Number 74120152

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 12/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that left hip revision surgery was performed due to high metal ion levels and loosening.Competitor femoral stem remained in place.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.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, head & sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the cup.Similar complaints have been identified for the head and sleeve and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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 and no further actions are required at this time.The medical records were reviewed.The received surgical report of revision states that a staining fluid which was usually present with mom wear was detectable intraoperatively.However, the received medical record states that the joint ¿fluid which was clear from the wear¿ and none of the received pathological reports mentions the presence of signs of wear.Based on the received lab reports the reported, in respect to reference values of the lab, elevated blood metal ion level is comprehensible.However the measured value is below the threshold for chromium and cobalt referenced in the medical device alert, issued by mhra.It was noted that use of a competitor¿s (hayes) femoral stem was implanted with the bhr cup & hemi head at the time of revision.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: BHR ACETABULAR CUP 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 5513262
• MDR Text Key: 40734108
• Report Number: 3005477969-2016-00070
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 085380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided; 04/30/2020
• Supplement Dates FDA Received: 06/30/2016; 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HAYES FEMORAL STEM, # (B)(4); HEMI HEAD, # (B)(4), LOT # 08EW17109; MODULAR SLEEVE, # (B)(4), LOT # 08BW15722
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 95