MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 07/01/2019

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to persistent pain, elevated test results and metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed on a bilateral patient.During the revision the acetabular cup, hemi head and modular sleeve were removed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup, head & sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for head, cup and sleeve this 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.Device history record review confirmed that all released parts met specifications applicable at the time of production.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 result of the reported event.The medical documents were reviewed.The reported pain, elevated cobalt and chromium levels and intraoperative findings of significant fibrosis around the hip joint, chronic inflammation with signs of hemorrhagic bleeding and pigment containing macrophages withinin the synovial tissue may be consistent with findings of metallosis and synovitis.However, without the supporting imaging, and/or the analysis of the explanted components, the root cause of the reported pain and elevated cobalt and chromium levels, and synovitis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined 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: ACETABULAR CUP HAP SIZE 44/50
• 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: 9606668
• MDR Text Key: 175653979
• Report Number: 3005975929-2020-00021
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2014
• Device Model Number: 74122150
• Device Catalogue Number: 74122150
• Device Lot Number: 09EW23461
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122544/ 08LW19984.; MODULAR SLEEVE 74222100/ 09BW21797.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR