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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis due to the location is 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: 0002648920 - 2020 - 00514.0001822565 - 2020 - 03938.

Event Description

It was reported by 411 that a patient underwent a left hip arthroplasty on an unknown date.Subsequently, the patient was revised on an unknown day for the cup being flat needing to come out.X rays were provided and showed dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This report was submitted in error and the final report will be submitted on 0001822565 - 2020 - 04130.

Event Description

This report was submitted in error and the final report will be submitted on 0001822565 - 2020 - 04130.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10904797
• MDR Text Key: 218272798
• Report Number: 0001822565-2020-03939
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN STEM; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR