MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Unintended Movement (3026)

Patient Problems Pain (1994); Injury (2348); Test Result (2695)

Event Date 01/16/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Pain, metallosis, pseudotumour and loose acetabuar component reported.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, metallosis, pseudotumour and loose acetabular component.During the surgery bhr cup, hemi head and modular sleeve were removed, 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 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 mechanical symptoms and sensations of instability, elevated cobalt concentration approximately the 8 fold compared to the chrome concentrations and an mri showed a pseudotumor in the rectus tendon.During the revision, metallosis in the capsule with metal stained fluid in the hip, metallic damaged tissue at the gluteus medius, scar tissue at the trunnion and trunnionosis, a loose cup and mobility in the posterior wall as well as a bone insufficiency anterior inferior to the acetabulum.Based on the provided information and without the devices available for analysis it remains unclear whether the loose cup was a result of the reported findings or contributed to them.Other possibly contributing factors such as implant position could not be assessed as no x-rays were provided.Without histopathological analysis, the nature of the reported tissue changes remains unclear.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

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.- attachment: [196332.Pdf].

• Brand Name: BHR ACETABULAR CUP 54MM
• 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: 7548121
• MDR Text Key: 109364118
• Report Number: 3005975929-2018-00180
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 74122154
• Device Lot Number: 09BW21857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71306110, LOT # 01EM13312A; HEMI HEAD, # 74122548, LOT # 08KW19414; MODULAR SLEEVE, # 74222100, LOT # 08GW17828; FEMORAL STEM, # 71306110, LOT # 01EM13312A; HEMI HEAD, # 74122548, LOT # 08KW19414; MODULAR SLEEVE, # 74222100, LOT # 08GW17828
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR