MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 1 PC SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 10/30/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: catalog number:14-380353, lot number:198770, brand name: monm m2a38 hd.Catalog number:7100100306, lot number: 2008090173, brand name: ppf ltz stem sz 06x160mm.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2020-02380.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.

Event Description

It was reported that the patient experienced pain approximately 4 years post implantation but refused the proposed revision surgery.The patient underwent blood tests approximately 9 years post implantation which resulted in elevated metal ion level.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  the following sections were  updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.

• Brand Name: M2A 1 PC SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10163476
• MDR Text Key: 195531388
• Report Number: 0001825034-2020-02381
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 15-105052
• Device Lot Number: 529970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other