MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR STEM, STANDARD, UNCEMENTED, HA, 5, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: exact stem removal jaw; catalog no#: x31-400060; lot#: 443702.Therapy date: (b)(6) 2020.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to bone fracture.
Additional Manufacturer Narrative
Additional information which was received on nov 5, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer did not receive any documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(6).
Event or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to bone fracture.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the patient had a hip replacement in (b)(6) 2020.Patient sustained a femur fracture due to a fall and was revised on (b)(6) 2020.Review of received data: medical data was not provided.Product evaluation: the product was discarded; therefore, visual evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient had a hip replacement in (b)(6) 2020.Patient sustained a femur fracture due to a fall and was revised on (b)(6) 2020.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the description, it can be assumed that the femur fracture was caused by the patient's fall.Nevertheless, the reported femur fracture could not be confirmed due to lack of medical data; therefore, no exact cause could be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: AVENIR STEM, STANDARD, UNCEMENTED, HA, 5, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10768653
• Report Number: 0009613350-2020-00516
• Device Sequence Number: 17166083
• Product Code: LZO
• UDI-Device Identifier: 00889024590991
• UDI-Public: 00889024590991
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.005
• Device Lot Number: 3008393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 02/12/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/17/2020; 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention