MAUDE Adverse Event Report: ZIMMER GMBH AVENIR®, STEM, LATERAL, CEMENTED, 2, TAPER 12/14; PROSTHESIS, HIP

Model Number	01.06010.302
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10.Avenirâ®, stem, lateral, cemented, 1, taper 12/14 item# 0106010301 lot# 3198852.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.
Event or Problem Description
It was reported that during an initial hip procedure, when the doctor tried to insert the stem, it sat up 1.5cm form where it was supposed to go.Another size of stem was implanted instead.No harm to patient was reported.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.Corrected: d4 (model number).The product involved in the reported event was returned for investigation.Visual examination of the device shows that there are light scratches and scuffs around the distal side of the stem.No other damage was noted during visual evaluation.A dimensional evaluation of the device was performed as well.Overall length, distance to etched line, and width/thickness of section views on distal end were measured with all dimensions measuring conforming.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional same or similar related complaints for this item and the reported part and lot combination.The product was returned for evaluation.A dimensional inspection was conducted, and all measured values were found to be within the specified tolerances.Accordingly, any dimensional nonconformity of the product can be excluded.Of note, in the provided pictures, the stem was trailed with the plastic cup still on the taper.It is not clear is this issue lead or contributed to the reported event.However, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: AVENIR®, STEM, LATERAL, CEMENTED, 2, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22453294
• Report Number: 0009613350-2025-00548
• Device Sequence Number: 8156061
• Product Code: LZO
• UDI-Device Identifier: 00889024590755
• UDI-Public: (01)00889024590755(17)300312(10)3226689
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 01.06010.302
• Device Catalogue Number: 0106010302
• Device Lot Number: 3226689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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.
• Patient Age: 73 YR
• Patient Sex: Female