MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 50ODX44ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Pain (1994)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Medical devices: item number: unknown, item name: unknown m2a magnum head, lot #: unknown; item number: unknown, item name: unknown m2a magnum taper, lot #: unknown; item number: unknown, item name: unknown stem, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08407.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent hip revision approximately 8 years post-implantation due to pain and elevated ion levels.Attempts have been made and no additional information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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

This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient underwent hip revision approximately 8 years post-implantation due to pain and elevated ion levels.Operative notes stated estimated blood loss of less than 100ml.It was also noted serum blood cobalt and chromium levels are markedly elevated.Patient has been evaluated for pseudotumors and/or disruption of her muscles or tendons in the hips which has not occurred.Fluid from the hip was exposed as yellow and thick viscosity but had no apparent debris or purulence and cultures were obtained.There was excellent exposure of the metal acetabulum without evidence of wear.No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM PF CUP 50ODX44ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7805765
• MDR Text Key: 117895204
• Report Number: 0001825034-2018-08408
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: US157850
• Device Lot Number: 640150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET M2A HEAD CATALOG#157444 LOT#771660; BIOMET M2A TPR INSRT CATALOG#139256 LOT#139256; BIOMET STEM CATALOG#UNK LOT#710260
• Patient Outcome(s): Hospitalization; Required Intervention