MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A MAGNUM CUP; PROSTHESIS HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk m2a magnum head.Unk taper adapter.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09298.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised approximately nine years post initial surgery due to pain, discomfort and elevated metal ion levels.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further information.

Manufacturer Narrative

Reported event was unable to be confirmed as part number/lot number of device involved in the incident is unknown.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.This follow-up report is being submitted to relay additional information.

• Brand Name: UNK M2A MAGNUM CUP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7942890
• MDR Text Key: 123055472
• Report Number: 0001825034-2018-09297
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2018
• 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