MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN MALLORY HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown liner, unknown, unknown, unknown shell, unknown, unknown, unknown stem, unknown.Implanted in 1993.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04154, 0001822565-2018-04155, 0001822565-2018-04156.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient has been indicated for revision due to unknown reasons.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

Event Description

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

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

Event Description

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

• Brand Name: UNKNOWN MALLORY HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7772491
• MDR Text Key: 116744572
• Report Number: 0001822565-2018-04153
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other