MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 6; PROSTHESIS, HIP

Catalog Number	574101060
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bone Fracture(s) (1870); Pain (1994); Seroma (2069); Ambulation or Postural Difficulties (2544)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total hip arthroplasty.Approximately two (2) weeks post-implantation, the patient experienced a twisting motion of the left leg which resulted in severe pain and an inability to walk.Diagnostic images revealed a periprosthetic trochanteric fracture and subsidence of the femoral stem.Subsequently, the patient underwent an uncomplicated fracture reduction procedure with revision of the femoral head and stem components.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: sulox-head 28 l 12/14: catalog#17.28.07, lot#3052661l20dural alpha insert w rim gg/28: catalog#01.00013.307, lot#3065509;allofit-s alloclas shell 48/gg: catalog#4263, lot#3065411.G2: foreign: germany.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a2; b4; b5; b7; g3; h2; h11.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.H6: proposed component code: mechanical (g04)- stem visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroplasty was performed.Two weeks later, a twisting trauma of the leg resulted in pain.A periprosthetic fracture was identified with subsidence.The stem was found loose and was removed, the fracture was reduced with cables.The head and stem were explanted and replaced with zb product.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial anatomic alignment of the left hip arthroplasty complicated by a periprosthetic femoral fracture.Subsequent revision with fracture fixation and anatomic alignment.Subsequent imaging demonstrates a new cone fracture as described.Root cause was unable to be determined however it was reported the patient sustained a twisting motion leading to the fracture and subsidence.Investigation results concluded that no device problem was found related to the seroma and wound complication as procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management reported event was confirmed by review of provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: AVENIR CMPL HA STD NC SIZE 6
• Common Device Name: 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: 19095635
• Report Number: 0001822565-2024-01226
• Device Sequence Number: 17994200
• Product Code: LZO
• UDI-Device Identifier: 00889024508668
• UDI-Public: (01)00889024508668(17)260131(10)3056726
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 574101060
• Device Lot Number: 3056726
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 08/22/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/03/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 110 KG