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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/11/2013

Event Type  Injury  

Event Description

Legal counsel patient reported that patient underwent an initial left hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reported patient allegations of pain, swelling, inflammation, damage to surrounding tissue and bone, lack of mobility, metallosis, metal poisoning, and loss of range of motion.Legal counsel alleged a revision procedure was performed on (b)(6) 2013 where the modular head and insert were removed and replaced.Legal counsel further alleged that a second revision procedure occurred on (b)(6) 2013 where the cup and insert 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 invoice history indicates that the modular head and taper adapter were removed and replaced with an active articulation liner and head during the revision procedure on (b)(6) 2013.Invoice history further suggests the acetabular cup, liner and head were replaced with competitor acetabular components and a biomet ceramic head on (b)(6) 2013.

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: "inadequate range of motion due to improper selection or positioning of components." and "intraoperative or postoperative bone fracture and/or postoperative pain." 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 1825034-2015-00734 & 00735 & 01170).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

Legal counsel patient reported that patient underwent an initial left hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reported patient allegations of pain, swelling, inflammation, damage to surrounding tissue and bone, lack of mobility, metallosis, metal poisoning, and loss of range of motion.Legal counsel alleged a revision procedure was performed on (b)(6) 2013 where the modular head and insert were removed and replaced.Legal counsel further alleged that a second revision procedure occurred on (b)(6) 2013 where the cup and insert 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 invoice history indicates that the modular head and taper adapter were removed and replaced with an active articulation liner and head during the revision procedure on (b)(6) 2013.Invoice history further suggests the acetabular cup, liner and head were replaced with competitor acetabular components and a biomet ceramic head on (b)(6) 2013.Additional information received in operative report noted patient was revised on (b)(6) 2013 due to metallosis, implant clicking and locking, and trochanteric bursitis.Operative report further noted a reactive capsule and fluid during the procedure.The modular head and taper adapter were removed and replaced and a liner was implanted.Operative report noted patient underwent a further revision procedure on (b)(6) 2013 due to recurrent dislocation and pain.During the procedure, a hematoma was noted.The modular head, acetabular cup and liner were removed and replaced with a biomet head and competitor acetabular components.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: CER BIOLOXD OPTION HEAD 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: 4637517
• MDR Text Key: 5612774
• Report Number: 0001825034-2015-01170
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2015

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 316130
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2015; 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2012
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR