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

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown head, pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-09555.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent a revision procedure approximately nine years post implantation due to pain, loosening, and metallosis.Surgeon noted some serous brown fluid in the joint.He also indicated that the acetabular component was mechanically loose and showed no evidence of ingrowth on the back side with soft bone and loss of bone within the acetabulum.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Event Description

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

Manufacturer Narrative

(b)(4).This report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information provided by customer.Device history record (dhr) was unable to be reviewed as lot numbers were not provided.A definitive root cause cannot be determined with the information 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.

Manufacturer Narrative

Upon receipt of additional information within medical records, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial and final reports were forwarded in error and should be voided.

Event Description

Upon receipt of additional information within medical records, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial and final reports were forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7951654
• MDR Text Key: 123236594
• Report Number: 0001825034-2018-09550
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,literature
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• 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: 07/09/2019
• 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