MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR HD 32MM X +0; PROSTHESIS, HIPS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Joint Dislocation (2374)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent a hip arthroplasty.Subsequently, the patient was revised one year post implantation due to dislocation due to placement of the acetabular component.The head, liner, and shell were exchanged.

Manufacturer Narrative

(b)(4).Concomitant medical products: 4265 allofit-s alloclas shell 52/ii 3065418.01.00013.509 dural alpha insert w rim ii/32 3060690.G2: report source: australia.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: ZB 12/14 COCR HD 32MM X +0
• Type of Device: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19006038
• MDR Text Key: 338939816
• Report Number: 0001822565-2024-01081
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024498839
• UDI-Public: (01)00889024498839(17)300930(10)3047396
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 802203202
• Device Lot Number: 3047396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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: 67 YR
• Patient Sex: Male