MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MOD HEAD; HIP PROSTHESIS

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Cyst(s) (1800); Pain (1994); Reaction (2414)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

Item #162252, bi-metric pc, lot #338400; item #15-105004, m2a taper liner, lot #915250.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2017-00512).

Event Description

Legal counsel for patient who underwent a total hip arthroplasty approximately 14 years ago reported patient allegations elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received in the patient's revision operative report noted patient was revised 14 years post-implantation.The revision operative report noted the presence of a mass coming from the hip capsule and substantial debris present.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2017-00511 ¿ hd, 0001825034-2017-00512 - cup, 0001825034-2017-05229 ¿ liner.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Reported event was confirmed based on medical records.There are warnings in the package insert that these types of events can occur and associated risks are addressed in risk documentation.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were 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 MOD HEAD
• Type of Device: HIP PROSTHESIS
• 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: 6312412
• MDR Text Key: 66830266
• Report Number: 0001825034-2017-00511
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 11-163669
• Device Lot Number: 661150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2002
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 82