MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 22.2MM DIA COCR MOD HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/05/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a total hip arthroplasty on an unknown date.Subsequently, a revision procedure has been indicated due to implant wear and/or fracture; however, no revision procedure has been reported to date.Additional information received noted that the patient underwent a hip revision on (b)(6) 2014 due to wear.The modular head was removed and replaced.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "wear and/or deformation of articulating surfaces.".

Event Description

It was reported that a patient underwent a total hip arthroplasty on an unknown date.Subsequently, a revision procedure has been indicated due to implant wear and/or fracture; however, no revision procedure has been reported to date.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).

Manufacturer Narrative

This follow-up report is being filed to correct information that was reported in error on a previous medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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: "wear and/or deformation of articulating surfaces." this report is number 1 of 2 mdr's filed for the same patient (reference 1825034-2014-07135 & 1825034-2015- 00921).

Event Description

It was reported that a patient underwent a total hip arthroplasty on an unknown date.Subsequently, the patient underwent a hip revision on (b)(6) 2014 due to wear.The modular head was removed and replaced.Additional information received indicates the patient underwent another revision procedure on (b)(6) 2015 due to dislocation.The acetabular cup, liner and head were removed and replaced.

• Brand Name: 22.2MM DIA COCR MOD HD STD NK
• 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: 4017297
• MDR Text Key: 4714130
• Report Number: 0001825034-2014-07135
• Device Sequence Number: 1
• Product Code: KMC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK853259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 163651
• Device Lot Number: 540640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 08/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/18/2014; 03/09/2015; 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2013
• 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