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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.X-ray review demonstrated that advanced liner wear of the left hip arthroplasty with eccentric head position as noted and elevated cup abduction angle.There is proximal femoral radiolucency without definite osteolysis although the image is limited.There is subluxation of the femoral head within the cup as noted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01107, 0001822565 - 2020 - 01142.

Event Description

It was reported the patient underwent an initial total hip arthroplasty on an unknown date.Subsequently the patient was revised due to liner wear.The liner was removed and replaced.Attempts have been made, however 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
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9898320
• MDR Text Key: 189876802
• Report Number: 0001822565-2020-01141
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 69 YR