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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Death (1802); Failure of Implant (1924); Unspecified Infection (1930); Scar Tissue (2060); Sepsis (2067); Joint Dislocation (2374); Paraplegia (2448); Swelling/ Edema (4577)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of death - 2018; date not provided.Additional concomitant medical products: unknown head; catalog number:00875705802 lot number:63290513 brand: tm modular shell; catalog number:00771301200 lot number:63346813 brand: tm modular shell.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01003, 0001822565-2019-01005, 0001822565-2019-01014.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that a patient underwent a total hip arthroplasty.Subsequently, it is alleged that the patient became partially paralyzed and began experiencing signs of infection within one (1) month post-operatively.The hip also allegedly "fell apart" approximately three (3) months post-operatively.The patient underwent revision due to infection approximately seven (7) months post implantation of the total hip arthroplasty.Dark metal stained fluid was noted and removed during the revision.The patient eventually passed away, following continued bouts with infection.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04174.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Concomitant medical product(s): 00771301200 modular femoral stem 63346813; 00875705802 shell with multi holes porous 63290513; 00877504002 bioloxâ® delta, ceramic femoral head 2823276; 00784801400 modular neck 61956654.Review of the sterility certificates identified no deviations or anomalies related to the reported event.After reviewing the medwatch details, it was found that the surgeon had left a washer in the patient after the tha procedure.It was also stated that the patient was paralyzed, meaning the hip was not in use leading to a loss in muscle tension and the overall integrity of the hip prosthesis.The patient additionally suffered from a bacterial meningomyelitis infection.Additional information does not change the outcome of the previous investigation.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 additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that patient underwent hardware removal after an unknown amount of time post implantation.Approximately 1 month later, the pateitn experienced a mid-thoracic complete spinal cord injury and myelomeningitis resulting in urosepsis and paraplegia.While in the rehab hospital, it was noted on x-ray that the neck had disassembled from the stem.All hip aspirations were negative for infection, however the surgeon wanted to revise due to increased swelling.During the surgery, some heterotopic ossification was noted and 5ml of dark stained fluid was aspirated from the joint.No obvious signs of infection were noted.All components were removed without complication and antibiotic cement beads were placed.The patient continued to experience ongoing infections until death approximately 1 year later.Attempted have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were received and reviewed by a health care professional.Pre-revision xrays show the modular neck had disassociated from the stem and the hip was essentially dislocated.During the procedure, dark stained fluid along the scar tissue was observed.Disassociation was confirmed and the components removed.The interface between the implant and the acetabular bone was evaluated and a small amount of micromotion was observed.Pseudomembrane was cultured.There was minimal ingrowth on the proximal portion of the stem.Additional information does not change the outcome of the previous investigation.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 additional event information to report 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: 8389698
• MDR Text Key: 137795774
• Report Number: 0001822565-2019-01016
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• 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: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other; Required Intervention
• Patient Weight: 83