MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994); Tissue Damage (2104)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803602 ¿ cocr head ¿ 62210493, 00630505036 ¿ xlpe liner ¿ 62175538, 00620205020 ¿ trilogy shell ¿ 61663552, 00625006535 ¿ bone screw ¿ 62239425.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.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: 0002648920-2020-00184.

Event Description

It was reported that patient underwent a right hip revision approximately 5 years post implantation due to pain, in-vivo corrosion, elevated metal ion levels, pseudotumor, altr, cyst and tissue damage.Findings include obvious corrosion debris throughout the capsule.At lease a grade ii taper corrosion was noted.A cyst was present with the iliopsoas bursa.The head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was confirmed by review of medical records noting patient underwent a revision surgery due to pain, corrosion, pseudotumor and elevated metel ion levels.During the revision altr, cyst, and tissue damage were found.A 10ml sample of dark gray colored synovial fluid was sent for cell count and culture using chem strip.Chem strip was equivocal due to the presence of metal debris.Obvious corrosion debris noted throughout the capsule.A cyst was present within the ilioposis bursa.Dhr was reviewed and no discrepancies were found.The root cause is 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 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.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: M/L TAPER FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9985497
• MDR Text Key: 188486205
• Report Number: 0001822565-2020-01423
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 65771100900
• Device Lot Number: 62130249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 57 KG