MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR STEM, STANDARD, UNCEMENTED, 2, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device, 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.(b)(4).
Event or Problem Description
During total hip arthroplasty, when implanting the avenir stem the patient's femur got fractured.The surgeon attempted to remove and replace the stem with two avenir extractors but the attempt was failed which caused a surgical delay of 1 hour.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6 correction: d3, b4, b5, g4, g7, h10 event description: during a tha surgery, while implanting an avenir size 2 stem the femur fractured.The surgeon removed the stem to stabilize the fracture and inserted a longer cemented stem.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: during a tha surgery, while implanting an avenir size 2 stem the femur fractured.The surgeon removed the stem to stabilize the fracture and inserted a longer cemented stem.Neither x-rays, operative notes nor the device or photos of the device were received.Patient factors that may have affected the performance of the component such as bone quality and anatomy of the femur are unknown.Based on the missing medical records the reported event cannot be confirmed.The complained device was not returned; therefore, visual and dimensional evaluation could not be performed.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 significant lack of information, we were neither able to confirm nor to identify a specific root cause for the reported event.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 cmp(b)(4).

• Brand Name: AVENIR STEM, STANDARD, UNCEMENTED, 2, 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: 10592509
• Report Number: 0009613350-2020-00425
• Device Sequence Number: 17095448
• Product Code: LZO
• UDI-Device Identifier: 00889024590939
• UDI-Public: 00889024590939
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.002
• Device Lot Number: 3001882
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization