MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER OPTION TYPE 1 TPR SLEVE +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Discharge (2225); Disability (2371); Ambulation Difficulties (2544)

Event Date 04/09/2014

Event Type  Injury  

Event Description

It was reported that patient underwent total hip arthroplasty (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2014 due to an abscess on hip.The modular head and acetabular cup were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received from patient¿s legal counsel reports patient underwent a right hip revision on due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, dysfunction, loss of range of motion and lack of mobility.Additional information provided in patient medical records indicates patient is bilateral with left hip arthroplasty performed on (b)(6) 2005.Review of invoice history could not confirm the left hip arthroplasty.There has been no reported revision of the left hip.Additional information provided in patient medical records indicates right hip revision performed on (b)(6) 2014 was due to swelling and drainage from sinus of prior incision/pseudotumor.The patient¿s operative report noted gray reactive tissue.Additional information provided in patient medical records indicates additional right hip revision performed on (b)(6) 2014 due to infection.The patient¿s operative report noted irrigation and debridement was performed, and also noted was wound weeping, fibrinous and edematous looking tissue.

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.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.¿ this report is number 6 of 6 mdrs filed for the same patient (reference 1825034-2014-03234 / 03235 and 07595 / 07598).

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +3
• 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: 4082432
• MDR Text Key: 4852954
• Report Number: 0001825034-2014-07598
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2014

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: Physician
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-1067
• Device Lot Number: 712900
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• 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: 67 YR