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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Osteopenia/ Osteoporosis (2651); No Information (3190)

Event Date 05/17/2019

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 was requested but not returned by the hospital.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: cup: 0001822565-2019-02792, liner: 0001822565-2019-02793.

Event Description

It was reported that a patient underwent a right hip arthroplasty on an unknown date.Subsequently, the patient was revised for an unknown reason.Cup and liner were revised.Attempts have been made and no further information has been provided.

Manufacturer Narrative

The reported event was confirmed by review of radiographs.Review of radiographs demonstrated that asymmetric position of the femoral head within the acetabular cup consistent with polyethylene wear.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined with the information available.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8755141
• MDR Text Key: 149850015
• Report Number: 0001822565-2019-02792
• Device Sequence Number: 1
• Product Code: KWY
• 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
• Report Date: 08/12/2019

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
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR