MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122152

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 08/15/2011

Event Type  Injury  

Event Description

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

Manufacturer Narrative

It was reported that a right 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.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup or head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 available medical documents were reviewed.: based on the information provided, the intraoperative findings of greyish fluid and brownish synovium may be consistent with findings associated with metal debris.However, without the supporting radiographic images, lab/pathology results, and/or the analysis of the explanted components, the reported possibility of aseptic lymphocyte-dominant vasculitis-associated lesion 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 revision is expected post-operative healing/pain.The patient¿s continued right hip/groin pain and two subsequent revisions are not related to s&n devices.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.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: ACETABULAR CUP HAP SIZE 44/52
• 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: 9309497
• MDR Text Key: 165976780
• Report Number: 3005975929-2019-00400
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

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: No Information
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74122152
• Device Lot Number: 08DW16862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 06/24/2020; 08/18/2020
• Supplement Dates FDA Received: 06/25/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123144 FEM HEAD 44MM 08HW18442
• Patient Outcome(s): Hospitalization; Required Intervention