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

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown liner, 010000662 6449985 g7 pps ltd acet shell 50d, 00625006530 64339340 bone scr 6.5x30 self-tap, unknown head.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implnated.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: 0001825034 - 2019 - 03770, 0001825034 - 2019 - 03771.

Event Description

It was reported during hip surgery, the liner would not seat into cup.A second liner was opened and used.Upon reduction, the hip was determined to be unstable.After interop x-ray was performed, it was determined that the cup had moved during impaction of the second liner.The liner and femoral stem were removed, the cup was repositioned, screws were inserted, a new liner was inserted, the stem was re-inserted and the hip was reduced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8923862
• MDR Text Key: 155321592
• Report Number: 0001825034-2019-03772
• Device Sequence Number: 1
• Product Code: KXA
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PROSTHESIS, HIP
• Patient Outcome(s): Required Intervention