MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIV RNGLC SHL 52MM/L23; PROSTHESIS, HIPS

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported the cup was unstable due to the age of the implant.Implant was twenty (20) years old.Subsequently, the patient was revised.

Manufacturer Narrative

(b)(4).D10: 103532, ti low profile screw 6.5x25mm, 183090.163653, 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: 0001825034-2024-00710.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.

• Brand Name: UNIV RNGLC SHL 52MM/L23
• 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: 18897184
• MDR Text Key: 337587273
• Report Number: 0001825034-2024-00711
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921301
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-103552
• Device Lot Number: 352570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female