MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET MAGNUM M2A-38 CUP; HIP PROSTHESIS

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Depression (2361)

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.Implanted in 2009.Concomitant medical products: item # unk, hip-mom-heads-unk, lot # unk, item # unk, hip-unknown-stems-unk, lot # unk.The event occurred in italy.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10974, 0001825034-2018-10976.

Event Description

It was reported that the patient was implanted in the right hip with magnum m2a-38 devices approximately 9 years ago.Subsequently, the patient is affected by depression because of the periodical follow up for elevated ion levels.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

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) 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 additional event information to report at this time.

• Brand Name: UNKNOWN BIOMET MAGNUM M2A-38 CUP
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8116803
• MDR Text Key: 128860522
• Report Number: 0001825034-2018-10974
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other