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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0001822565-2023-03645
• Device Sequence Number: 15129154
• Product Code: LZO
• UDI-Device Identifier: 00889024508798
• UDI-Public: (01)00889024508798(17)280414(10)3149381
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown