MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER OPTION TYPE 1 TPR SLEVE -6; PROSTHESIS, HIP

Model Number N/A

Device Problems Entrapment of Device (1212); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Synovitis (2094); Tissue Damage (2104); Toxicity (2333); Joint Dislocation (2374); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Fluid Discharge (2686); Test Result (2695)

Event Date 04/12/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2008 and a right total hip arthroplasty on (b)(6) 2010.Patient's legal counsel further reports patient allegations of pain, loss of range of motion, elevated metal ion levels and metallosis.Subsequently, patient's legal counsel reported patient underwent a revision procedure on an unknown side on (b)(6) 2011 and a left hip revision procedure on (b)(6) 2013.Review of invoice histories confirmed the modular head and taper adapter were removed and replaced in both procedures.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 operative (op) notes reports patient underwent a left hip revision on (b)(6) 2011, due to patient allegations of painful popping and snapping with left anterior groin pain, unequal leg lengths, and difficulty with day to day activities.Left revision op report notes yellow, viscous fluid; gray staining of the synovium; cavity defect; and an osteophyte were observed.Additionally, the left acetabular component was observed to be retroverted with subluxation and disruption of the fascia lata, and the femoral component was observed to be at approximately ten degrees of anteversion.The head and taper insert were removed and replaced.The cup was removed and replaced with a competitor product.Additional information received from the patient¿s op notes reports patient underwent a right hip revision on (b)(6) 2012, due to patient allegations of pain.Right revision op notes report yellow, cloudy fluid with white precipitate; acetabular osteophytes; and acetabular synovitis were observed.Additionally, impingement of the anterior acetabulum was noted against the edge of the femoral neck with a five degree anteversion within the shell and a 35 to 40 degrees horizontal incurvation.The head and taper insert were removed and replaced.The cup was removed and replaced with a competitor product.

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 1 states, "material sensitivity reactions." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 9 of 9 mdrs filed for the same event (reference 1825034-2014-00319 / -00324 and -02369 / -02371).

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -6
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3721197
• MDR Text Key: 4274755
• Report Number: 0001825034-2014-02371
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070274
• 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: 03/05/2014

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 650-1064
• Device Lot Number: 037880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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: 53 YR