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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Reaction (2414)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04156.

Event Description

It was reported that patient underwent a left hip revision approximately 6 years post implantation due to metallosis, loosening, pseudocapsule, osteolysis/bone loss and migration.A new head and taper along with competitor product were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Review of medical records noting metallosis with aseptic loosening.Cultures sent for gram stain and culture & sensitivity (no report provided).Pseudocapsular tissues were removed from the posterior aspect of the greater trochanter.Upon entering the joint space, moderate amount of seropurulent appearing fluid was encountered likely related to the metal wear debris (if pathology report is obtained and it is consistent with infection, complaint categories will be updated).The acetabular shell was found to be grossly loose and malrotated.The acetabulum was devoid of bone and communicated directly with the true pelvis.Intra-operative x-rays confirmed satisfactory placement of implants, leg length, and offset.No intra-operative complications identified.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is 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 HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10885800
• MDR Text Key: 217709321
• Report Number: 0001825034-2020-04157
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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: 10/30/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP.; UNKNOWN STEM.; UNKNOWN TAPER.; UNKNOWN CUP; UNKNOWN STEM; UNKNOWN TAPER
• Patient Outcome(s): Hospitalization; Required Intervention