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

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146); Osteolysis (2377); Sleep Dysfunction (2517)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned for the investigation as the product location is 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: 0001825034 -2019 -04624.

Event Description

It was reported that patient underwent a right hip revision approximately 18 years post implantation due to recurring pain, liner wear and ostosis at the acetabular interface.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected reported event was confirmed by review of medical records noting patient reports progressive pain, groin burning, and leg swelling interfering with adls and sleep.X-rays note retroverted acetabular component position, significant liner wear and periacetabular osteolysis.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.

Event Description

It was reported that patient presented to physician reporting progressive pain, groin burning, and leg swelling that interfered with activity of daily living and sleep approximately 18 years post implantation.X-rays taken at that time noted significant wear of the liner component.Patient ultimately underwent a right hip revision approximately 4 months later.Attempts have been made and additional information is unavailable at this time.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9186244
• MDR Text Key: 170048791
• Report Number: 0001825034-2019-04623
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 12/31/2019

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?: Yes
• 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: 09/19/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK CUP; UNK HEAD; UNK STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 110