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

Catalog Number 74120160

Device Problems Mechanical Problem (1384); Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348)

Event Date 12/03/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metal ion levels, mechanical complications and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to elevated metal ion levels, mechanical complications and metallosis.As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.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, hemi head and modular sleeve 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.The available medical documents were reviewed.Cobalt and chromium levels were 5.0 and 1.0 mcg/l respectively.The intraoperative report indicated metallosis staining and trunnionosis.Specimens were sent to pathology, however no results were provided.The reported pain, elevated cobalt and trunnionosis are 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Further, 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
• 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: 7432057
• MDR Text Key: 105508254
• Report Number: 3005975929-2018-00125
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 74120160
• Device Lot Number: 10FW28621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM # 71306115, LOT # NI; HEMI HEAD, # 74122554, LOT # NI; MODULAR SLEEVE, # 74222200, LOT # NI; PART# 74122554, LOT 08BW15613; FEMORAL STEM # 71306115, LOT # NI; HEMI HEAD, # 74122554, LOT # NI; MODULAR SLEEVE, # 74222200, LOT # NI
• Patient Outcome(s): Hospitalization; Required Intervention