MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HEXLOC LINER; HIP PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.The following could not be completed with the limited information provided.Age or date of birth - ni, weight - ni, date of death - ni, date of event - ni, device code - ni, expiration date - ni, date implanted - ni, date explanted - ni, (b)(6), manufacture date ¿ ni.

Event Description

Information was received based on review of a journal article titled, "no improvement in long-term wear and revision rates with the second-generation biomet cup (ringloc) in young patients" which aimed to examine the clinical results following total hip arthroplasty in a study of 111 patients younger than 55 years that experienced possible poor performance of cementless titanium acetabular components using the hexloc system and mallory head acetabular components manufactured by biomet; and to investigate the whether results could be improved with a second-generation design, the ringloc.Twenty-two patients were identified in the article that underwent hip arthroplasties on unknown dates.Patient follow-up results provided indicate that the patients underwent hip arthroplasty revisions due to liner wear and/or acetabular loosening.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to correct information previously reported.If another follow-up is needed another report will be submitted.

Event Description

It was reported in a journal article, 22 patients underwent total hip revision procedures due to liner wear.Attempts have been made and additional information on the reported events is unavailable.

• Brand Name: UNKNOWN HEXLOC LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6085047
• MDR Text Key: 59344512
• Report Number: 0001825034-2016-04506
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention