MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM 28MM RNGLOC LNR 10DEG25; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/15/2002

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a total hip arthroplasty on mar(b)(6) 2000.Subsequently, patient's legal counsel reports patient allegations of pain, bone/tissue damage, lack of mobility, loosening and metallosis.Review of invoice history indicates patient underwent a revision procedure on (b)(6) 2002.The modular head and femoral stem was 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 in the operative report noted patient underwent a right hip revision procedure on (b)(6) 2002 due to loosening.Revision operative report noted the presence of fibrous tissue with granulomatous disease and a loose stem.The modular head and stem were removed and replaced.Operative report further noted patient underwent an additional right hip revision on (b)(6) 2002 due to dislocation.Operative report noted the presence of an osteophyte and nonunion of a fractured greater trochanter.The modular head, liner and acetabular cup 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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." 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 4 mdrs filed for the same patient (reference 1825034-2014-06538 /-06539 & 2015-01103 /-01104).

• Brand Name: ARCOM 28MM RNGLOC LNR 10DEG25
• 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: 4621473
• MDR Text Key: 5656475
• Report Number: 0001825034-2015-01103
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK926107
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2004
• Device Model Number: N/A
• Device Catalogue Number: 11-105915
• Device Lot Number: 790910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/1999
• 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