MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120164

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Debris, Bone Shedding (1803); Pain (1994); Toxicity (2333); Patient Problem/Medical Problem (2688); Test Result (2695); No Code Available (3191)

Event Date 06/08/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed pain, metallosis trunnionosis, pseudotumor and extensive bone loss.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup and hemi head.Similar complaints have been identified for the sleeve and this failure 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 review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 a result of the reported event.The available medical documents were reviewed.The clinical information provided, of the pain, metallosis, a large pseudotumor and extensive bone loss, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It is unknown what impact the patient¿s congenital bone deformity in their right hip had on the wear of the bhr components.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 64MM
• 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: 8304063
• MDR Text Key: 134966085
• Report Number: 3005975929-2019-00055
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502636
• UDI-Public: 03596010502636
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: 74120164
• Device Catalogue Number: 74120164
• Device Lot Number: 076014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 75002704, LOT # E0805918; HEMI HEAD, # 74122558, LOT # 10734; MODULAR SLEEVE, # 74222300, LOT # 07K14074; FEMORAL STEM, # 75002704, LOT # E0805918; HEMI HEAD, # 74122558, LOT # 10734; MODULAR SLEEVE, # 74222300, LOT # 07K14074
• Patient Outcome(s): Hospitalization; Required Intervention