MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X30MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 11-107323 ¿ freedom liner ¿ 483900 103531 ¿ ti low profile screw ¿ 866700; 103531 ¿ ti low profile screw ¿ 490870; 103533 ¿ ti low profile screw ¿ 089760; 103534 ¿ ti low profile screw ¿ 595460; 103200 ¿ taperloc stem ¿ 143910; 11-107016 ¿ freedom head ¿ 519710; 106054 ¿ ranawat/burstein shell ¿ 345600.Device manufacture date: sep 2006.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 and once the investigation is complete, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02984, 0001825034-2020-03760, 0001825034 - 2021 - 00397, 0001825034 - 2021 - 00399, 0001825034 - 2021 - 00400.

Event Description

It was reported that patient underwent a right hip revision approximately 3 months post implantation and a second revision approximately 13 years later due to pain, osteolysis and screw loosening resulting in liner wear.The head and liner 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.Reported event was confirmed by review of medical records.Findings included pain, osteolysis and screw loosening which caused liner wear.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 further event information available at the time of this report.

• Brand Name: TI LOW PROFILE SCREW 6.5X30MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11302253
• MDR Text Key: 230996641
• Report Number: 0001825034-2021-00398
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 103533
• Device Lot Number: 227790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 83