MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM ONE PIECE CUP SZ 54MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Metal Shedding Debris (1804); Failure to Align (2522); Naturally Worn (2988)

Patient Problems Toxicity (2333); Reaction (2414); Test Result (2695)

Event Date 09/20/2012

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.A review of the provided data and the visual examination of the components have indicated the presence of wear stripes on the femoral head and wear patches on both bearing surfaces, including adjacent to the rim on the cup.These features likely indicate that a degree of edge loading or subluxation of the parts occurred.Such mechanisms may arise when the acetabular component is sub-optimally positioned or if the patient has a degree of joint laxity.The stem was also noted to be in 5° valgus and to be undersized.These effects could have been further exacerbated by the loading through the joint, which, considering that the patient's bmi indicates that patient was obese, could be considered to have been excessive.The heavy scratching and indentations on the bearing surfaces suggest that a third body was present, the source of which is unclear.Additionally, the black band of staining on the female taper indicates that a fretting or galling process occurred, most probably due to the elevated stresses at the taper interface in response to the above adverse loading.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 1 of 2 mdrs filed for the same event (reference 1825034-2015-04518 / 04519).

Event Description

It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2012 due to wear, joint laxity, undersized stem, adverse reaction to metal debris, elevated metal ion concentration, and misaligned components on an unknown date.Reported from (b)(6) laboratory.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6), 2012 due to wear, joint laxity, undersized stem, adverse reaction to metal debris, elevated metal ion concentration, and misaligned components.Reported from south hampton laboratory.

• Brand Name: M2A 38MM ONE PIECE CUP SZ 54MM
• 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: 5206012
• MDR Text Key: 30580170
• Report Number: 0001825034-2015-04518
• 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,Followup
• Report Date: 01/25/2016

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: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 15-105054
• Device Lot Number: 488830
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2006
• 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: 55 YR
• Patient Weight: 78