MAUDE Adverse Event Report: Zimmer Biomet, Inc. AVENIR CMPL HA VAR COL SIZE 2; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer

Catalog Number	574203020
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a primary total hip arthroplasty, a size 2 coxa vara femoral stem became firmly engaged distally during insertion and remained proud by approximately 1 to 2 cm, resulting in an intraoperative revision.During femoral preparation, the canal was rasped to size 2 and trialed with a coxa vara configuration, which was deemed to provide an appropriate fit.Upon implantation, the stem could not be advanced further despite multiple attempts.Extraction instruments were not available in theatre, necessitating an extended trochanteric osteotomy to facilitate removal.There was a significant intraoperative delay while additional instrumentation was transported from another site.Following removal of the stem, reconstruction was completed using an alternative stem and cone body.The patient underwent an extended trochanteric osteotomy and was reconstructed intraoperatively with an alternative stem and cone body.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).E1: (b)(6).G2: foreign - event occurred in united kingdom.H6: proposed component code : mechanical (g04) - stem.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: AVENIR CMPL HA VAR COL SIZE 2
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer
• 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 ; +1(574)526-0384
• MDR Report Key: 50725408
• Report Number: 0001822565-2026-03091
• Device Sequence Number: 18788373
• Product Code: LZO
• UDI-Device Identifier: 00889024509276
• UDI-Public: (01)00889024509276(17)310407(10)3268945
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/10/2026

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 Catalogue Number: 574203020
• Device Lot Number: 3268945
• Was Device Available for Evaluation?: Yes
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown