MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD +3MM; PROTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/13/2024

Event Type  Injury  

Event Description

It was reported that the patient had a right total hip arthroplasty on an unknown date, and a right hip revision approximately three years ago due to recurrent dislocations.Subsequently, the patient was revised a second time approximately one month ago due to recurrent dislocations.No additional information available.

Manufacturer Narrative

(b)(4).A2: date of birth: information provided by the hospital showed the date of birth documented as two different dates: (b)(6) 1947 and (b)(6) 1948.D10: cat# unknown lot# unknown-unknown zimmer biomet unk 4-finned acetabular shell.Cat# unknown lot# unknown-unknown zimmer biomet stem.Cat# 105424 lot# 655270 rnglc locking ring sz 24.Cat# ep-105894 lot# 214770 epoly rlc 36mm 10deg sz24.G2: foreign: country: australia.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: 36MM COCR MOD HD +3MM
• Type of Device: PROTHESIS, HIP
• 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: 19110676
• MDR Text Key: 340231879
• Report Number: 0001825034-2024-01025
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304210530
• UDI-Public: (01)00880304210530(17)270822(10)614570
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032396
• 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: 04/15/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-363663
• Device Lot Number: 614570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female