MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122548

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Local Reaction (2035); Injury (2348); No Code Available (3191)

Event Date 12/05/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to adverse local reaction to metal.

Event Description

Acetabular cup remained implanted.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The bhr cup and anthology stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.Since device part details were not received for investigation, no thorough manufacturing record review can be performed.The available medical documents were reviewed.Bilateral revisions were performed 7 years post implantation.Cobalt and chromium levels august 2017 were 16.83 and 3.2ng/ml respectively.An mri showed alval bilaterally.The revision intraoperative findings were adverse local tissue reaction and mild metal transfer at femoral taper.Pain, elevated cobalt and chromium levels, pseudotumor, alval and trunnionosis are consistent with 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, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.It was noted that use of a competitor¿s (biomet) dual mobility liner was implanted with the bhr cup 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: HEMI HEAD 48MM
• 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: 7296145
• MDR Text Key: 100920132
• Report Number: 3005975929-2018-00064
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122548
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2018
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 4122154, LOT # NI; FEMORAL STEM, # 71357106, LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # UNKNOWN; FEMORAL STEM, # 71357106, LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR