MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP FEM HD COCR CEMENTED DIA 48MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Problem (1384); Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.An examination of the components has indicated the presence of a feint wear patch and a wear stripe on the femoral resurfacing head in addition to one wear stripe on the acetabular cup.Such mechanisms may arise when the acetabular component is sub-optimally positioned or if the patient has a degree of joint laxity; however radiographs and patient/surgical information would be required to confirm this.The adverse wear may have been further exacerbated by the presence of a third body between the bearing surfaces, which likely caused the scratches and indentations that are evident on both the femoral head and acetabular cup; the source of the third body remains unknown.In this instance, the nature of the "armd and mechanical complication of the internal joint prosthesis" which was reported as the reason for revision is unclear.The absence of surgical/patient information and radiographs prevents any of these mechanisms from being confirmed.Hence the root cause for the revision of the components cannot be determined with the information provided.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 11 states, "wear and/or deformation of articulating surfaces.".

Event Description

It was reported that patient underwent a femoral resurfacing hip procedure on (b)(6) 2007.Subsequently, patient underwent a revision procedure on (b)(6) 2015 due to adverse reaction to metal debris (armd) and mechanical complication of the internal joint prosthesis.During the procedure, the resurfacing head and shell were removed and replaced.

• Brand Name: RECAP FEM HD COCR CEMENTED DIA 48MM
• Type of Device: PROSTHESIS, HIP
• 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: 5353066
• MDR Text Key: 35345349
• Report Number: 0001825034-2016-00091
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 157248
• Device Lot Number: 135190
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2004
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention