MAUDE Adverse Event Report: ZIMMER GMBH AVENIR STD STEM CEMENTED 2; HIP PROSTHESIS

Catalog Number	01.06010.202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bursitis (4832)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a clinical study that a patient experienced a fall into a wall and subsequently presented with trochanter bursitis approximately 3 months post implantation.The patient was treated with medical blockade and implants remain implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: g7 pps ltd acet shell 50d , #item 010000662, #lot 7464476 g7 vit e high wall lnr, #item 30123604, #lot 65612905 zb 12/14 cocr hd, #item 802203602, #lot 3110068 therapy date: (b)(6) 2023 g2:foreign source denmark an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
Follow up report.Updated: b4,b5,d2,g1,g3,g6,h1,h2,h6.Review of the reported event by a health care professional found: bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that postop bursitis developed and required medical intervention for treatment.Product has not been evaluated as it has been determined the event is not related to device.The root cause of the reported event was determined to be unrelated to the device.This is a limited investigation, as review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.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.
Event or Problem Description
No additional information.

• Brand Name: AVENIR STD STEM CEMENTED 2
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22943150
• Report Number: 0009613350-2025-00686
• Device Sequence Number: 15894879
• Product Code: LZO
• UDI-Device Identifier: 00889024590762
• UDI-Public: (01)00889024590762(17)261022(10)3080557
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 01.06010.202
• Device Lot Number: 3080557
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2021
• 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: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 65 KG