MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI METRIC/XR LAT RPP C/L 8MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Compatibility Problem (2960)

Patient Problems Host-Tissue Reaction (1297); Osteolysis (2377); Reaction (2414)

Event Date 02/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant products - m2a-magnum pf cup 46odx40id/ pn us157846/ ln 342330, selex/magnum mod hd 40mm -3/ pn s031140/ ln 218320.It is unknown if the device will be returned for analysis, as its location is unknown.Once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-03027-1, 0001825034-2017-03540.

Event Description

It was reported that patient underwent a right hip revision approximately five years post implantation due to instability, osteolysis, pseudotumor, metal on metal allergic type response, and synovitis.Operative notes indicate that the patient had no gluteus minimus and capsule, and was basically direct to the hip joint.There was also severe soft tissue lytic areas as well as a massive pseudotumor over the greater trochanter.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: BI METRIC/XR LAT RPP C/L 8MM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6609431
• MDR Text Key: 76570307
• Report Number: 0001825034-2017-03541
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: X11-180438
• Device Lot Number: 057290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: Not provided; 09/29/2017
• Supplement Dates FDA Received: 06/19/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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: 67 YR