MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122554

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 05/30/2008

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to length discrepancy, peri-prosthetic fracture.Head and sleeve exchanged.

Manufacturer Narrative

It was reported a right hip revision surgery was performed.During the revision the femoral head and modular head sleeve were removed.The anthology femoral stem and acetabular cup remained implanted.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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.The patients right periprosthetic femur fracture and subsidence of the stem was a result of trauma sustained in an mva and cannot be 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.Based on the available information a potential root cause of an adverse incident has been selected due to the patient being involved in an mva shortly after the initial surgery and the subsidence in the stem appearing immediately after this event.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.Additional information: patient identifier and other relevant history.

• Brand Name: HEMI HEAD 54MM
• 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: 9372003
• MDR Text Key: 167954894
• Report Number: 3005975929-2019-00410
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071854
• UDI-Public: 00885556071854
• 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
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2012
• Device Catalogue Number: 74122554
• Device Lot Number: 11319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120160/ 080165.; ANTHOLOGY STEM 71356013/ 06LM16097.; HEMI HEAD 74122554/ 07EW11882.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR