MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ENDO II MOD ENDO HEAD SZ 54; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804); Residue After Decontamination (2325); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problems Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 09/04/2014

Event Type  Injury  

Event Description

Legal counsel reported patient underwent right total hip arthroplasty on (b)(6) 2005.Legal counsel further reports patient allegations of pain and difficulty walking.No revision procedure has been reported to date.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received from complaint report noted that the patient underwent a right hip revision on (b)(6) 2014.The presence of metallosis was noted during the revision procedure.The modular head and acetabular cup were removed and replaced.Additional information received in patient operative (op) report dated (b)(6) 2014 notes the presence of yellowish fibrous tissue, grayish capsular tissue, cloudy fluid, black residue on taper of neck and metal head, scratches on the head, and cup over-hang.The stem was well-fixed.Cup and head were removed and replaced with a unipolar head as a spacer.Subsequently, patient underwent a second revision procedure (b)(6) 2014 due to infection and recurrent dislocations.Revision op report further notes that the femoral shaft fractured below the trochanteric osteotomy that was performed to remove the well-fixed stem.The head and stem were removed and replaced with antibiotic spacers.

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 associated deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, it states: "dislocation and subluxation due to inadequate fixation and improper positioning." & "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 4 of 4 mdrs filed for the same event (reference 1825034-2014-05470 /-07601 & 2015-00412 / 00413).

• Brand Name: ENDO II MOD ENDO HEAD SZ 54
• 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: 4471467
• MDR Text Key: 5562285
• Report Number: 0001825034-2015-00413
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK984028
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 12-139032
• Device Lot Number: 209260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• 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: 55 YR