MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM PF CUP 56MM O.D. X 50MM I.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Delamination (2904)

Patient Problems Pain (1994); Reaction (2414); Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2015

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.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 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 based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-03801 / 03802).

Event Description

Patient's legal counsel reported patient underwent left total hip arthroplasty and approximately five years post-implantation.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative record reported revision due to pain, metallosis, and pseudotumor formation.During the procedure, a pseudotumor, well-fixed stem, and metal debris were noted.During removal of the acetabular shell, it was noted the porous coating had delaminated.Removal of the coating required additional instrumentation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device was not returned so no product evaluation could be conducted.This device was used for treatment.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A MAGNUM PF CUP 56MM O.D. X 50MM I.D.
• 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: 5984895
• MDR Text Key: 55872552
• Report Number: 0001825034-2016-03802
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

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: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 820580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2009
• Is the Device Single Use?: No
• 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: 70 YR