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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110030153 dm univ prov brg 22.2 x 32mm 978660, item #: unknown liner lot #: unknown, item #: unknown stem lot #: unknown, item #: unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00653 trial bearing.

Event Description

It has been reported the mobility trial came off of the femoral head and got stuck in the soft tissue in pelvis.It was successfully removed.Attempts were made to obtain additional information; however, none is available at this time.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed by visual examination of provided photograph of the bearing.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

It has been reported dr.Hebert, was doing a trial reduction with our dual mobility trial and the dual mobility trial came off of the femoral head and got stuck in the soft tissue in pelvis.A general surgeon was call to remove the provisional.Surgery was delayed an hour.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN TRIAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9695767
• MDR Text Key: 178786233
• Report Number: 0001825034-2020-00654
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 54