MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR TROCH GRIP 2.0MM/MEDIUM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Discolored (1170); Fracture (1260); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 05/22/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent right total hip arthroplasty on (b)(6) 2008.Patient's legal counsel reports patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, dislocations, and metallosis.It was further reported that revision procedures occurred on (b)(6) 2008, (b)(6) 2012, and (b)(6) 2013.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in patient operative (op) notes dated (b)(6) 2008 reports patient was revised due to pain and loosening.Revision op report notes the femoral component was dislocated superiorly and the acetabular component rotated 180 degrees.The cup and head were removed and replaced.Additional information received in patient op notes dated (b)(6) 2012 reports the cup was vertical and retroverted with evidence of impingement.In addition, revision op report notes evidence of metallosis and edge wear at the superior aspect of the femoral head at the acetabular junction, metal oxidative and corrosive changes at the femoral trunnion as well as the femoral head taper, periarticular and peritrochanteric fluid collection with avascular necrotic tissue and metal staining, and a greater trochanter fracture at a previous drill hole site.The head and taper were removed and replaced.The cup was removed and replaced with a competitor product.Additional information received in patient op notes dated (b)(6) 2013 reports the patient was revised due to chronic dislocation and non-union fracture.Revision op notes report evidence that the trochanteric claw was no longer capturing the greater trochanter fracture.In addition, a metallosis deposit was noted.The modular head and trochanteric claw were removed and replaced.

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 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning." 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.¿ this report is number 5 of 6 mdrs filed for the same event (reference 1825034-2014-03938 / -03940, -03959, -07502/-07503).

• Brand Name: COCR TROCH GRIP 2.0MM/MEDIUM
• 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: 4060165
• MDR Text Key: 16632284
• Report Number: 0001825034-2014-07502
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982545
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 120007
• Device Lot Number: 121110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2011
• 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: 58 YR