MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 PPS LTD ACET SHELL 58G; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Neuropathy (1983); Limited Mobility Of The Implanted Joint (2671)

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 2 states, ¿early or late postoperative infection and/or allergic reaction.¿ number 6 states, "inadequate range of motion due to improper selection or positioning of components." this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.

Event Description

It was reported that patient underwent a left total hip arthroplasty on (b)(6) 2014.Subsequently, approximately two (2) months later patient experienced cipd (chronic inflammatory demyelinating polyneuropathy) and is being tested for suspected metal allergy.Patient alleges limited mobility, limited ability to walk or climb stairs and lack of mobility of his fingers.A revision procedure has not been reported at this time.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: G7 PPS LTD ACET SHELL 58G
• 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: 5303888
• MDR Text Key: 33685521
• Report Number: 0001825034-2015-05002
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000666
• Device Lot Number: 3054343
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other