MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H10 NARRATIVE; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Insufficient Information (3190)

Patient Problems Local Reaction (2035); Scar Tissue (2060); Tissue Damage (2104); No Information (3190)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00877703604, bioloxâ® option, head 2859580, 00630505836, liner standard 3.5 mm offset 36 63587992, item #: unknown, unknown cup, lot #: unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04237, liner.

Event Description

Legal report alleges patient underwent a tha and subsequently was revised eleven years later for unknown reasons.Attempts were made to obtain additional information; however, none was available.

Event Description

It was reported that the patient had a revision surgery eleven years after initial tha due to elevated metal ions, and feeling of instability.Surgeon notes corrosion and altr.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Brand name: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 15 standard offset.This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records indicate that the patient underwent a revision procedure due to elevated metal ions and instability.During the procedure, yellow cloudy fluid was observed.Stained tissues were present with mild inflammation.Upon removal of the head, there was corrosion on the head's taper and the stem.Small yellow colored plastic fragments were noted between the poly and metal cup.The head, liner, and locking ring were removed and replaced with new zimmer biomet products.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

It was reported that the patient had a revision surgery eleven years after initial tha due to elevated metal ions, and feeling of instability.Operative report notes yellow cloudy fluid present, not black tissue encountered.Stained tissues present with mild inflammation.Head was removed noting trunionosis and corrosion of the head and stem.Small yellow colored plastic fragments noted between poly and metal cup.Fragment was sent to pathology and it "appears to be some form of plastic foreign body." attempts were made to obtain additional information; however, none was available.

• Brand Name: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9139292
• MDR Text Key: 161813418
• Report Number: 0001822565-2019-04239
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00771101500
• Device Lot Number: 60786397
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other; Required Intervention