MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 56/62; BHR ACETABULAR CUP

Catalog Number 74122162

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Injury (2348); Arthralgia (2355)

Event Date 01/27/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to failed hip arthroplasty.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to failed hip arthroplasty.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 known 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.Since no underlying medical documents were received for investigation, no thorough medical investigation and assessment of the reported complaint can be performed.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.

Event Description

It was reported that a right revision surgery was performed on (b)(6) 2015 due to failed hip arthroplasty and possible adverse reaction to metal.Primary right bhr hip surgery was performed on (b)(6) 2008.

• Brand Name: ACETABULAR CUP HAP SIZE 56/62
• Type of Device: BHR ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone
• MDR Report Key: 7929221
• MDR Text Key: 122448302
• Report Number: 3005975929-2018-00352
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2024

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 Expiration Date: 08/31/2011
• Device Catalogue Number: 74122162
• Device Lot Number: 9290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 09/12/2018; 12/16/2020; 04/10/2024; 05/02/2024
• Supplement Dates FDA Received: 03/12/2019; 12/21/2020; 04/23/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMRL HEAD 56MM 74123156 LOT 08DW16680.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male