MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/24/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on left hip due to pain and dislocation.

Manufacturer Narrative

It was reported that a revision surgery was performed on left hip due to pain and dislocation of the hip.During the revision the bhr cup and bhr head 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.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.According to the provided revision report, the final diagnosis was failed resurfacing and pain.No information on the dislocation was provided.No additional details on the reasons for this revision were provided.Review of the provided implantation and revision report did not reveal any inconsistencies related to the surgical technique that could explain or have contributed to the revision.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: ACETLR CUP HAP 52MM 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; UK
• MDR Report Key: 7613795
• MDR Text Key: 111474900
• Report Number: 3005975929-2018-00221
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

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: 03/31/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 73347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 06/01/2022
• Supplement Dates FDA Received: 03/22/2019; 06/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2007
• 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: BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; FEMORAL HEAD 46MM 74121146 LOT 74042; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male