MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A HI CARBON HD -3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Reaction (2414)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0001825034-2017-05956, 0001825034-2017-05957.Concomitant medical products: unknown magnum cup p/n unknown l/n; unknown magnum femoral head p/n unknown l/n unknown.A revision has occurred, but it is unknown if the device(s) will be returned for evaluation at this time.The information is being followed up upon.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that the patient underwent right hip revision due to pain and elevated metal ion levels.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.Concomitant medical products: 15-103682, m2a-t univ 2-hole shl sz 41/52, lot 789640.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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

Reported event was confirmed by review of operative notes.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-03297, 0001825034-2017-05957.

Event Description

It was reported that a patient underwent a revision surgery approximately 9 years post implantation due to pain, metallosis, alval, and elevated ion levels.The capsule was clearly evident as it was darkly stained in contrast to surrounding gluteus medius and posterior per sciatic fat.Attempts have been made, and no further information has been provided.

• Brand Name: 32MM M2A HI CARBON HD -3MM NK
• 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: 6792228
• MDR Text Key: 82661671
• Report Number: 0001825034-2017-05957
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-163687
• Device Lot Number: 885540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2006
• 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: 60 YR