MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SELEX/MAGNUM MODULAR HEAD 40MM -6; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Disability (2371); Reaction (2414); No Information (3190)

Event Date 05/08/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2015 due to unknown reasons.The acetabular cup and modular head were replaced and an acetabular liner was implanted.

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.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which 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, number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain.".

Event Description

It was reported that patient underwent initial total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2015 due to patient allegations of pain.The acetabular cup and modular head were replaced and an acetabular liner was implanted.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which 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, number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 1 of 2 mdr's filed for the same event (reference 1825034-2015-02456-2 / 2016-00493).

Event Description

It was reported that patient underwent initial total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2015 due to patient allegations of pain, disability and elevated metal ion levels.The acetabular cup and modular head were replaced and an acetabular liner was implanted.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

Patient's legal counsel reported that patient underwent a left hip revision procedure approximately 8 years post-implantation due to allegations of pain, disability and elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.It was confirmed in operative report received that patient underwent a left hip revision procedure approximately 8 years post-implantation due to metallosis, pain and elevated metal ion levels.During the procedure, fluid containing evidence of metallosis and a lack of bony ingrowth on the acetabular component were noted.The acetabular cup and modular head were replaced and an acetabular liner was implanted.

• Brand Name: SELEX/MAGNUM MODULAR HEAD 40MM -6
• 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: 4826466
• MDR Text Key: 5842247
• Report Number: 0001825034-2015-02456
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,oth
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2016

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: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: S061140
• Device Lot Number: 410910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/10/2015; 02/12/2016; 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2005
• 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: 61 YR