MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HEAD; PROSTESIS, HIP

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/17/2019

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 location is unknown.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical products: item# unk/ unk stem/ lot # unk, item# unk/ unk cup / lot # unk, item# unk/ unk liner/ lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 -05482, 0001822565 - 2019 -05485, 0001822565 - 2019 -05486.

Event Description

It has been reported that patient has sustained 2 separate injuries due to unknown reasons, however no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

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 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

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

Manufacturer Narrative

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

• Brand Name: UNK HEAD
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9527009
• MDR Text Key: 176475932
• Report Number: 0001822565-2019-05480
• Device Sequence Number: 1
• Product Code: LZO
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/06/2020; 03/03/2021
• Supplement Dates FDA Received: 01/10/2020; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other