MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 0 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71332752

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Swelling (2091); Toxicity (2333); Injury (2348)

Event Type  Injury  

Event Description

It was reported a left hip revision surgery due to metal-on-metal failure including elevated cobalt levels, armd, metal stained tissue, metallosis, and pseudotumor.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.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.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Risk management reviews were performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewedthe implantation operative report was reviewed.However, it does not aid in the medical investigation of the reported post-implantation elevated cobalt levels, adverse reaction to metal debris, metal stained tissue, metallosis, and pseudotumor.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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: R3 0 DEG XLPE ACET LNR 36MM X 52MM
• 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: 9871110
• MDR Text Key: 184628034
• Report Number: 3005975929-2020-00081
• 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: 09/08/2020

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: 71332752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/08/2020
• Patient Sequence Number: 1
• Treatment: 71335552 R3 3 HOLE ACET SHELL 52MM; 71343604 OXINIUM FEM HD 12/14 36 MM M/+4; HEMI HEAD, PART # 74122552, LOT # UNKNOWN; UNKN ANTHOLOGY HIP IMPL (STEM); HEMI HEAD, PART # 74122552, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention