MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA HO NC SIZE 6; PROTHESIS, HIPS

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Implant Pain (4561)

Event Date 08/25/2023

Event Type  Injury  

Event Description

It was reported the patient was diagnosed with peri prosthetic fracture.The patient was having more than normal pain at rehabilitation.There was no trauma or sudden pain reported.Patient had a ct scan that revealed a femoral fissuration with a 2-3mm subsidence of the stem compared to the direct post op radiograph.A cerclage of the femur was performed, and all implants maintained implanted.

Manufacturer Narrative

(b)(4).D10: 00877503602 biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14 unknown 010000703 g7 bonemaster ltd acet shl 52e 7500034 30103605 36mm i.D.Size e neutral liner 65619431 g2: foreign: belgium no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial anatomic alignment of the right hip arthroplasty complicated by a non-displaced periprosthetic fracture of the femur with subsequent implant subsidence.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: AVENIR CMPL HA HO NC SIZE 6
• Type of Device: PROTHESIS, 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: 18334468
• MDR Text Key: 330595667
• Report Number: 0001822565-2023-03645
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024508798
• UDI-Public: (01)00889024508798(17)280414(10)3149381
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K182048
• 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: 12/14/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 574102060
• Device Lot Number: 3149381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization