MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA VAR NC SIZE 5; PROSTHESIS, HIP

Catalog Number 574103050

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00623; 0001822565-2024-00624; 0001825034-2024-00483.D10: cat #: 30123605 / g7 vit e high wall lnr 36mm e / lot #: 65312753.Cat #: 802203603 / zb 12/14 cocr hd 36mm x +3.5 / lot #: 3089098.Cat #: 010000663 / g7 pps ltd acet shell 52e / lot #: 7132998.G2: denmark.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported during a clinical study that at the one-year post-op appointment, the patient was experiencing moderate pain, difficulty with ambulation and daily activities.Subsidence of the stem was noted as well.Then, the patient underwent a right hip revision approximately two years post implantation due to pain, difficulty with ambulation and daily activities.The patient was removed from the study and a revision of all the components was completed without any known complications.Attempts have been made and no further information is available.

• Brand Name: AVENIR CMPL HA VAR NC SIZE 5
• Type of Device: PROSTHESIS, HIP
• 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: 18758153
• MDR Text Key: 335999445
• Report Number: 0001822565-2024-00625
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K182048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

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 Catalogue Number: 574103050
• Device Lot Number: 3064721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/22/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 83 KG