MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID HIP PROSTHESIS

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Death (1802); Pain (1994); Discomfort (2330); Reaction (2414)

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 remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant product(s): item # unk, hip-unknown; item # 157446, head; item # 139254, taper insert. Report source: legal notification. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-08503, 0001825034-2018-08505.

Event Description

It was reported that a patient was implanted right hip with mom devices approximately 10 years ago and developed elevated ion levels. The patient expired on x(date) from heart and renal failure. Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This 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.

Event Description

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

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7818363
• MDR Text Key: 118287532
• Report Number: 0001825034-2018-08503
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: US157854
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 08/27/2018 Patient Sequence Number: 1