MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Chills (2191)

Event Date 07/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620205422 shell porous with cluster holes 54 mm, 00625006530 bone screw self-tapping 6.5 mm dia.30 mm length, 00630505036 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells.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 - 05173, 0001822565 - 2019 - 05174, 0001822565 - 2019 - 05176.

Event Description

It was reported patient underwent a left total hip arthroplasty.Subsequently, the patient was revised approximately one month post implantation after the patient experienced fever, chills, redness around the incision, elevated inflammatory levels, and positive aspiration cultures indicating infection.All implants were removed during revision.An extensive hematoma was evacuated, but no implant defects were found.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

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 a girdlestone was performed on an unknown date due to perioprosthetic hip infection from unknown products.The patient was revised, placed on iv antibiotics until discharge and oral antibiotics for 4 weeks post-operation.The patient received 8 units prbc, which was most likely due to patient's comorbidities and history of post-operation anemia.Decubitus first degree was noted on the heel; however the patient has circulation comorbidities that increase risk of pressure spots.The patient had difficulty breathing from heart failure and hypertension that were treated by adjusted blood pressure medications, diuretics, and inhalers.Post-operative x-rays were normal.The patient was then revised again due to increase in inflammatory labs and positive culture aspiration extensive subcutaneous and sub facial hematoma was noted.The implants were removed and replaced with unknown product.The patient was placed on antibiotics post-operation.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.

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 the following a girdlestone was performed on an unknown date due to periprosthetic hip infection from unknown products.The patient underwent a surgical procedure to implant the zimmer biomet products, placed on iv antibiotics until discharge and oral antibiotics for 4 weeks post-operation.The patient received 8 units prbc, which was most likely due to patient's comorbidities and history of post-operation anemia.Decubitis 1st degree was noted on the heel; however the patient has circulation comorbidities that increase risk of pressure spots.The patient had difficulty breathing from heart failure and hypertension that were treated by adjusted blood pressure medications, diretics, and inhalers.Post-operative x-rays were normal.The patient was then revised due to an increase in inflammatory labs and positive culture aspiration.Extensive subcutaneous and sub facial hematoma noted.The implants were removed and replaced with unknown product.The patient was placed on antibiotics post-operation.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9434826
• MDR Text Key: 170023667
• Report Number: 0001822565-2019-05175
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: N/A
• Device Catalogue Number: 00625006535
• Device Lot Number: 61454725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• 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