MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SELEX/MAGNUM MOD HD 40MM STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problems Abscess (1690); Debris, Bone Shedding (1803); Purulent Discharge (1812); Unspecified Infection (1930); Damage to Ligament(s) (1952); Necrosis (1971); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 03/26/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on (b)(6) 2011.Patient's legal counsel further reported patient allegations of pain, lack of mobility, damage to bone/tissue, metal poisoning, metallosis and elevated metal ion levels.Subsequently, patient underwent a revision procedure on (b)(6) 2013.A review of the invoice history confirmed the surgery dates and indicates the modular head, taper adapter and acetabular cup was 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 in the patient's revision operative report noted the reason for revision on (b)(6) 2013 was loosening of acetabular component.Operative report further noted significant metallosis, large pseudotumor, visible metallosis, necrotic tenderness, bony debris, soft tissue edema, and scar tissue during the revision.The acetabular cup was removed and replaced by competitor products.Additional information received in the patient's revision operative report noted patient underwent a right hip revision on (b)(6) 2013 due to infection.The head, cup, and liner were removed and replaced with antibiotic spacers.Operative report further noted patient underwent multiple previous irrigation and debridement's.Additionally, patient underwent another revision surgery on (b)(6) 2013 due to swelling, dislocation of antibiotic spacers, and formation of abscess.Operative report further noted large amount of reddish thick purulent material.The wound went through thorough irrigation and debridement and wound vac sponges were placed.

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: "early or late postoperative infection and allergic reaction." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2014-06617 & 06618).

• Brand Name: SELEX/MAGNUM MOD HD 40MM STD
• 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: 4753146
• MDR Text Key: 5827151
• Report Number: 0001825034-2015-01883
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: S001140
• Device Lot Number: 041330
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• 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 Age: 61 YR