MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 089712

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

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 11/27/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.The patient reported soreness and heat in the hip.

Event Description

It was reported that 2-stage left hip revision surgery was performed.(b)(6) 2017 chromium 78.4 ug/l and cobalt 47.4.The patient reported sorness and heat in the hip.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the hemi head, bhr cup and modular sleeve were removed.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.The clinical information provided, of the elevated metal ion levels and metal necrosis and debris may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Also it should be noted that an infection after 9 years in situ is likely haematogenous in nature and it is unknown how much the onset of diabetes with the hemoglobin a1c level at 14 contributed to the issue.All the released devices involved met manufacturing specifications at the time of production.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.Additional information: event, brand name,and concomitant medical products.

• Brand Name: ACETLR CUP HAP 54MM W/ IMPTR
• 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: 8386053
• MDR Text Key: 137676513
• Report Number: 3005975929-2019-00101
• Device Sequence Number: 1
• Product Code: NXT
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 089712
• Device Lot Number: 74120154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD 46MM 74122546/08CW16104; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE -4MM 12/14 74222100/11038; MODULAR SLEEVE, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR