MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC TI LOW PROFILE SCREW 6.5X25MM; PROSTHESIS, HIPS

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 11-103552, univ rnglc shl 52mm/l23, 352570.163653 22.2mm, dia cocr mod hd -3mm nk, 107230.Rd115915, arcom rngloc lnr lpw 22mm, 23 245490.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00711.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 the cup was unstable due to the age of the implant.Implant was twenty (20) years old.Subsequently, patient underwent a revision.

Event Description

No additional event information to report at this time.

• Brand Name: RINGLOC TI LOW PROFILE SCREW 6.5X25MM
• Type of Device: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18897180
• MDR Text Key: 337587243
• Report Number: 0001825034-2024-00710
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 103532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female