MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 40MM +3 HIWALL LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Naturally Worn (2988)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Fibrosis (3167)

Event Date 05/20/2014

Event Type  Injury  

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 6 states, "inadequate range of motion due to improper selection or positioning of components." number 11 states, "wear and/or deformation of articulating surfaces." number 14 states, "postoperative bone fracture and pain" this report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-05290 / 1825034-2016-00005).

Event Description

Patient reported to have undergone total right hip arthroplasty on (b)(6) 2010.Patient alleges constant pain, implant popping and clicking, instability, loss of range of motion, leg varus and leg length discrepancy.Patient further reported that a revision procedure was performed on (b)(6) 2014.A review of invoice history confirms both procedure dates and reveals that the modular head was removed and replaced during the revision.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Additional information received reported during a (b)(6) 2014 office visit, the patient had previously fallen as a result of pain and required a wheelchair.Operative report noted the patient was revised on (b)(6) 2014 due to aseptic loosening of the acetabular component, slight vertical orientation to the cup, acetabular wear, pain, and "polyethylene lining of the ball and socket had separated." during the procedure, a stable stem, poly wear, osteolysis, little bone fixation in cup, fibrous tissue which most likely caused pain, leg length discrepancy, and excess scar tissue were noted.The cup, liner, and head were removed and replaced with competitor cup and liner and zimmer biomet head.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device history files found no evidence of product non-conformance.Review of the device confirmed the reported complaint, as wear of the device was noted.During examination, scratches and a deformed surface were also noted.However, a conclusive root cause of the event could not be determined.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant products: biomet integral femoral stem catalog#: x12-171311 lot#: 884450.Biomet low profile screw catalog#: 103536 lot#: 284050.Biomet low profile screw catalog#: 103534 lot#: 262990.Biomet apical plug catalog#: 123741 lot#: 349170.Biomet ceramic femoral head catalog#: 650-1058 lot#: 361900.Biomet ceramic taper adapter catalog#: 650-1066 lot#: 142200.

• Brand Name: E-POLY 40MM +3 HIWALL LNR SZ24
• 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: 5341110
• MDR Text Key: 34960801
• Report Number: 0001825034-2016-00005
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: EP-108524
• Device Lot Number: 244080
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2010
• 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: 57 YR
• Patient Weight: 96