MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHETIC, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02570, 0001822565 - 2021 - 02571, 0001822565 - 2021 - 02573.

Event Description

It was reported the patient underwent an initial tha.Subsequently the patient was revised due to unknown reasons one (1) month ago.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records 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

It was reported the patient underwent a tha on an unknown date.Subsequently the patient was revised one month ago due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12475089
• MDR Text Key: 271528259
• Report Number: 0001822565-2021-02572
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: 09/17/2021
• 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