MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA COCR MOD HD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 01/02/2006

Event Type  Injury  

Event Description

Legal counsel for patient reported that the patient underwent a right total hip arthroplasty on (b)(6) 2005.Patient's legal counsel further reported patient was revised on (b)(6) 2006 due to patient allegations of pain.This report is based on allegations set forth in plaintiff¿s notice and the allegations there in are unverified.

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.The following sections could not be completed with the limited information provided.Brand name; product / lot code / expiration date; pma/510(k) number ; manufacture date.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "intraoperative or postoperative bone fracture and/or postoperative pain." this report is based on allegations set forth in plaintiff¿s notice and the allegations there in are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 6 mdrs filed for the same event (reference 1825034-2015-00381 & 01859 & 01871 & 01872 & 01904 & 01905).

Event Description

Legal counsel for patient reported that the patient underwent a right total hip arthroplasty on (b)(6) 2005.Patient's legal counsel further reported patient was revised on (b)(6) 2006 due to patient allegations of pain.This report is based on allegations set forth in plaintiff's notice and the allegations there in are unverified.Additional information received in operative report noted patient underwent a right hip revision procedure on (b)(6) 2006 due to unspecified acetabular complications.Operative report further noted disassociation between the modular head and acetabular cup, reactive tissue and thickened capsular tissue.All components were removed and replaced.Operative report noted patient underwent a left total hip arthroplasty on (b)(6) 2005.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Device not returned by attorney.

• Brand Name: 28MM DIA COCR MOD HD -6MM 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: 4460861
• MDR Text Key: 19718367
• Report Number: 0001825034-2015-00381
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2016

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: 08/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 163660
• Device Lot Number: 739450
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2015; 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2005
• 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: 43 YR