MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 05/04/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain and elevated ion levels.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular 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.The part / lot details provided for the right side index was a copy of the devices used for the left side index implantation.Therefore, no details are available for right side, and a documentation review could not be completed.If more information is received, this investigation will be reopened.The available medical documents were reviewed.The reported intraoperative findings of elevated metal ion levels, fluid, and corrosion may be consistent with findings associated with metal debris.However, the patient¿s comorbidities, past pelvic fractures and history of radiation and multiple steroid injections post tha, cannot be excluded as a contributing factors which could affect bone quality and positioning.The root cause of the reported clinical symptoms cannot be confirmed, and it cannot be concluded that the reported reactions/events 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.Additional information: brand name and concomitant medical products.

• Brand Name: HEMI HEAD 50MM
• 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: 9217457
• MDR Text Key: 163117021
• Report Number: 3005975929-2019-00381
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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
• Report Date: 12/02/2019

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 Catalogue Number: 74122550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 12/02/2019
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 56MM 74120156/ UNKNOWN; ANTHOLOGY STEM 71356106/UNKNOWN; HEMI HEAD, # 74122550, LOT # 10303; MODULAR SLEEVE 74222300/ UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # 9768; HEMI HEAD, # 74122550, LOT # 10303; MODULAR SLEEVE, # 74222300, LOT # 9768
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR