MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD -6MM NK; HIP PROSTHESIS

Model Number N/A

Event Date 08/06/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 15-105052, cup, lot # 862960.

Event Description

It was reported that a patient underwent a revision surgery approximately 8.5 years post implantation due to pain, squeaking, metallosis and pseudotumor.Approximately 6 months prior to the revision surgery, the patient presented with severe pain and squeaking.During the revision a 5cm pseudotumor was excised.The tissue had a classic metallosis like appearance.Pathology of the explanted device showed evidence of chronically inflamed fibroadipose tissue with focal necrosis.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

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 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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of operative notes.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

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

• Brand Name: M2A 38MM MOD HD -6MM NK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7802400
• MDR Text Key: 117791405
• Report Number: 0001825034-2018-08337
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

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: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 11-173660
• Device Lot Number: 523100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 10/31/2018; 03/19/2019
• Supplement Dates FDA Received: 11/06/2018; 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ITEM # 11-103207. STEM, LOT # 449570
• Patient Outcome(s): Hospitalization; Required Intervention