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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Unspecified Infection (1930); Necrosis (1971); Hypovolemia (2243)

Event Date 09/08/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00630506036 liner standard 3.5 mm offset 36 mm i.D.For use with 60 mm o.D.Shell.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device 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: 0001822565 - 2019 - 05193.

Event Description

It was reported that after a left total hip arthroplasty, the patient experienced multiple complications including conical implant fracture leading to extensive metallosis and tissue damage resulting in gluteal insufficiency and pseudarthrosis from trochanteric fractures.The patient underwent a second revision procedure during which the head, liner, and proximal body femoral components were exchanged due to exacerbated complications of the metallosis / tissue damage.Subsequently, the patient underwent removal of all components with implantation of an antibiotic cement spacer due to another periprosthetic infection and soft tissue necrosis.The patient required post-op hemodynamic stabilization but was discharged without further complication and declining inflammatory labs.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records received.Review of the available records identified presence of a chronic periprosthetic infection.All implants were removed and a cement spacer was implanted.Metallotic tissue interspersed within tissue, necrotic tissue was resected.Osteotomy performed to remove the femoral component.It was mentioned that the patient has previously experienced multiple complications including a conical implant fracture which lead to extensive metallosis and tissue damage which resulted in gluteal insufficiency and pseudarthrosis from trochanteric fractures.The patient underwent another revision in which the head, linear, and proximal body femoral components were exchanged due to metallosis and tissue damage.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

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

• Brand Name: UNKNOWN TM SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9437096
• MDR Text Key: 170029522
• Report Number: 0001822565-2019-05194
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00620206022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/10/2020
• 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): Hospitalization; Required Intervention