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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 02/14/2020

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 was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown femoral head, unknown liner, unknown shell, unknown augment.Report source: event occurred in (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00686, 0001822565 - 2020 - 00687.

Event Description

It was reported that in an unknown timeframe post implantation, the patient was revised of the hip components due to infection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to limited information received from the reporter.No devices, photos, or operatives notes were provided.X-rays were received and were of poor quality.Furthermore, evaluation of the x-rays would not enhance the investigation as the event is for infection.A review of the device history records was unable to be performed as the part and lot numbers were not provided.A definitive root cause cannot be determined.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: UNKNOWN FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9748062
• MDR Text Key: 189462856
• Report Number: 0001822565-2020-00685
• Device Sequence Number: 1
• Product Code: KWA
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention