MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 1 PC SHELL 38MMX50MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Particulates (1451); Device Slipped (1584); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Reaction (2414); Test Result (2695)

Event Date 11/06/2013

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.Device availability - product not returned to zimmer biomet facility.Zimmer biomet employees evaluated product at the (b)(6) facility.Review of the provided data and a visual examination of the revised components have indicated wear patches and wear stripes on the bearing surface of the femoral head, and a wear patch towards the rim of the acetabular cup.Such features are generally indicative of edge loading or rim contact of the cup, or subluxation of the components.It was reported during the revision surgery that the acetabular cup was loose; it is unclear if the probable adverse loading had a detrimental effect on the fixation.The scratches and indentations observed on the bearing surfaces are likely a result of the presence of a third body at this interface, the source of which is unclear.The female taper of the femoral head has some black residue in patches across its surface, which suggests that a fretting or galling process was active.Product left conforming to print as there was no evidence that states otherwise.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 4 states, "loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." number 11 states, "wear and/or deformation of articulating surfaces." 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 2 of 2 mdrs filed for the same event (reference 1825034-2015-04556/ 04557).

Event Description

It was reported that patient underwent an initial right total hip arthroplasty on (b)(6) 2008.Subsequently, the patient was revised on (b)(6) 2013 due to adverse reaction to metal debris (armd).It was further reported that the patient had particulate stained fluid that was yellow, black residue was present in patches, joint laxity, sub-optimal positioning, acetabular cup loosening, and third body wear.Reported from (b)(6) laboratory.

• Brand Name: M2A 1 PC SHELL 38MMX50MM
• 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: 5206476
• MDR Text Key: 30580336
• Report Number: 0001825034-2015-04557
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 15-105050
• Device Lot Number: 058920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2008
• 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: 74 YR
• Patient Weight: 54