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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651)

Event Date 04/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 32673200501 ¿ xlpe liner ¿ unknown lot; 00902603300 ¿ cocr head ¿ unknown lot; unknown stem ¿ unknown part and lot.Reported event was confirmed by review of x-rays reviewed by a third party hcp noting left total hip arthroplasty with screw fixation of the acetabular cup.There is a superior dislocation of the femoral head from the cup with suggestion possible fracture of the liner.Vertical position of the cup likely predisposes the patient to dislocation.There is also noted osteopenia.Dhr was unable to be reviewed as the lot number of the device is unknown.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01620, 0002648920-2020-00247.Device remains implanted.

Event Description

It was reported that patient underwent a hip revision after an unknown amount of time post implantation due to dislocation and liner wear.The head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

• 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: 10017225
• MDR Text Key: 189636393
• Report Number: 0001822565-2020-01621
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2020
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 97 YR
• Patient Weight: 59