MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FEMORAL HEAD RESURFACING 44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Synovitis (2094); Discomfort (2330)

Event Date 04/28/2014

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 1 states, "material sensitivity reactions." number 11 states, "wear and/or deformation of articulating surfaces." number 14 states, "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 2 of 2 mdrs filed for the same patient (reference 1825034-2016-03130 & 04018).

Event Description

Legal counsel for patient reported that patient underwent a right hip revision procedure approximately eight years post-implantation due to alleged pain, discomfort, soreness, dysfunction, and synovitis.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.It was reported in operative report received that patient underwent a right hip revision procedure approximately eight years post-implantation due to synovitis, wear debris and loosening of the acetabular component.During the procedure, all components were removed and replaced with legacy zimmer products.

• Brand Name: RECAP CEMENT FEMORAL HEAD RESURFACING 44MM
• 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: 6010469
• MDR Text Key: 56789892
• Report Number: 0001825034-2016-04018
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 157244
• Device Lot Number: 082800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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: 49 YR