MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER BIOLOXD OPTION HD 28MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Toxicity (2333); Osteolysis (2377); Fluid Discharge (2686)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Patient's legal counsel provided medical records that indicated the patient underwent right total hip arthroplasty on (b)(6) 2006.Revision operative notes revealed that a revision procedure was performed on (b)(6) 2014 due to pain, femoral stem loosening, elevated metal ion levels and osteolysis.Revision operative notes further revealed the presence of metal stained fluid and that the greater trochanter fractured and had to be cabled during the revision.The modular head and femoral stem were replaced and an active articulation liner was implanted.Revision operative notes indicate that a second revision procedure occurred on (b)(6) 2014 due to infection.An irrigation and debridement was performed and the stem, modular head, acetabular liner, cone body and taper were removed and replaced.

Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.There are warnings in the package insert that state that this type of event can occur: "early or late postoperative, infection, and allergic reaction." this report is number 5 of 8 mdrs filed for the same patient (reference 1825034-2015-02467 & 02468 & 02469 & 02470 & 02471 & 02472 & 02473 & 02474).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative, infection, and allergic reaction.¿ remains implanted.

Event Description

It was reported in operative notes that patient underwent a revision procedure approximately nine (9) days post-implantation due to infection.During the procedure, an irrigation and debridement was performed.The stem, modular head, acetabular liner, cone body and taper were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported in operative notes that patient underwent a revision procedure approximately nine (9) days post-implantation due to infection.Redness and swelling were noted.During the procedure, an irrigation and debridement was performed.The proximal stem component, modular head, acetabular liner, cone body and taper were removed and replaced.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• 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: 4825192
• MDR Text Key: 5909558
• Report Number: 0001825034-2015-02471
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 129110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• 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
• Patient Age: 52 YR