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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Irritation (1941); Pain (1994)

Event Date 09/29/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #unk , unknown stem, lot #unk; item #unk , unknown head, lot #unk; item #unk , unknown liner, lot #unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, location unknown.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: 0001822565 - 2019 - 01101; 0001822565 - 2019 - 01104.

Event Description

It was reported that a patient underwent a hip arthroplasty revision due to dislocation, sciatic nerve irritation and drop foot approximately 1 month post operatively.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was confirmed by review of medical records received.Revision operative notes stated that the patient had revision due to dislocation.Upon open the incision, there was a large hematoma.Some ingrowth was noted for the cup.New cup was implanted with approximately 25 degrees of anteversion and neutral with slight horizontal position.X-ray showed slight verticality; otherwise, it appeared within normal limits.Device history record (dhr) 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.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.

• 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: 8411429
• MDR Text Key: 138501730
• Report Number: 0001822565-2019-01103
• Device Sequence Number: 1
• Product Code: KWA
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• 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: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention