MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC/X POR NC LAT 8X120; PROSTHETIC, HIP

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Bacterial Infection (1735); Cyst(s) (1800); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Osteolysis (2377); Reaction (2414)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk cup, pn unknown, ln unknown.Unk head, pn unknown, ln unknown.Unk taper, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05778, 0001825034-2019-05779, 0001825034-2019-05780.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately 11 years post-implantation due to metallosis, infection and sepsis, necrosis and tissue damage.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

  once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

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.The following sections were updated/corrected updated: g3; h2; h3; h6 all devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As all product manufactured follow appropriate standards, and the reported infection occurred > 90 days, devices can be excluded as a possible source.A review of the device history records identified no deviations or anomalies during manufacturing for the cup.Medical records/radiographs were provided and reviewed by a health care professional.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level or better.Therefore, it is unlikely that the specified device caused any patient infection.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: BI-METRIC/X POR NC LAT 8X120
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9526841
• MDR Text Key: 185694276
• Report Number: 0001825034-2019-05781
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

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 Expiration Date: 12/31/2013
• Device Model Number: N/A
• Device Catalogue Number: X11-180308
• Device Lot Number: 333660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 05/11/2021; 06/03/2021
• Supplement Dates FDA Received: 06/01/2021; 06/04/2021
• 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