MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A HI CARBON HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Pain (1994); Loss of Range of Motion (2032); Reaction (2414)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 15-105044, m2a tpr hi carbon 41/32 mm lnr, 912570.The 15-103684, m2a-t univ 2-hole shl sz 41/54, 801490.X11-180312, bi-metric/x por nc lat 12x140, 774930.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04296, 0001825034-2018-04297, 0001825034-2018-04295.

Event Description

It was reported by the patient's legal counsel that the patient underwent left total hip arthroplasty.Subsequently, the patient underwent a revision procedure due to elevated ion levels.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).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) was reviewed and no discrepancies were found.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.

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent revision surgery approximately 9 years post initial surgery due to pain, limited range of motion, metallosis, pseudotumor and bone erosion.During the surgery it was found that anterior capsule had significant metallosis reaction and staining in the tissue.Radical resection removing the entire anterior and as much of the inferior and superior capsule.There was significant metallosis reaction around the acetabular implant with significant softening and bone loss.

Event Description

No further information was provided at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned.X-rays and medical records were reviewed and confirmed the reported event.Device history record (dhr) review identified no related manufacturing deviations or anomalies.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 HI CARBON HD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7647972
• MDR Text Key: 112700714
• Report Number: 0001825034-2018-04298
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-163688
• Device Lot Number: 767120
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention