MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOCLASSIC SL STEM 2 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This combined report is being submitted to relay additional information.Investigation of this event has been completed.During investigation this device was determined to be a main device and not a concomitant, therefore this report is being filed.Concomitant medical products metasul, alpha insert, hh/28 catalog: 01.00010.408; lot: 2500400.Metasul head 28mm m 12/14 catalog: 192806; lot: 2500153.Fitmore shell with screw cones, uncemented, 50/hh catalog: 01.00024.550; lot: 2512796.Investigation and conclusion: event description: the patient underwent a left total hip replacement procedure on (b)(6) 2010.Due to a periprosthetic femur fracture, the patient underwent revision surgery on (b)(6) 2022.Harm: s3 - bone fracture.Hazardous situation: reported issue is not device related.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: two undated radiographs of the left hip have been received.On the images a periprosthetic femur fracture can be seen.Stickers of revision surgery: during the revision surgery an arcos revision hip stem, a modular head and a durasul alpha insert were implanted together with cable wires.Images: a photograph was received showing the removed alloclassic stem with the head mounted and a polyethylene insert with a metasul inlay and a screw in the polyethylene.The parts show blood and soft tissue remnants.No product damages are visible.However, due to poor image quality (blurred photography), a detailed assessment cannot be made.Product evaluation: no product was returned; therefore, visual evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history record of the alloclassic stem identified no deviations or anomalies during manufacturing.Conclusion: the patient underwent a left total hip replacement procedure on (b)(6) 2010.Due to a periprosthetic femur fracture, the patient underwent revision surgery on (b)(6) 2022.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 radiographs the reported periprosthetic femur fracture can be confirmed.However, due to the lack of medical records such as patient visit notes and surgical notes, the reason for the periprosthetic fracture remains unknown.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).
Event or Problem Description
It was reported that a revision surgery took place, due to bone fracture.Investigation results are now available.Attempts have been made and no further information has been provided.

• Brand Name: ALLOCLASSIC SL STEM 2 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14301036
• Report Number: 0009613350-2022-00268
• Device Sequence Number: 17470301
• Product Code: LZO
• UDI-Device Identifier: 00889024590229
• UDI-Public: 00889024590229
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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): 05/03/2022

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: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00000002842
• Device Lot Number: 2521008
• 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: 04/13/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2009
• 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
• 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; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 70 KG