MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH ALLOCLASSIC, SL STEM, UNCEMENTED, 3, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: durasul, alpha insert, gg/32, item# 0100013407 , lot# 2556512; durasul, alpha insert, hooded, gg/28 , item# 0100013307.Lot# 2603104; cocr head 28/-4 's' 12/14 , item# 14280520 , lot# 2565408; fitmore, shell with screw cones, uncemented, 48/gg , item# 0100024548 , lot# 2629109; cancl bone scw ti 6.5mmx2 , item# 4301-07-025 , lot# 61787158.Report source - foreign: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that 10 years post-implantation, the patient underwent to revision surgery due to periprosthetic fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided: product evaluation could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.It was reported that the patient underwent a revision surgery on (b)(6) 2022 to correct periprosthetic fracture due to fall injury.Review of the device history record reported no deviation or anomalies during manufacturing, therefore, it is not expected that the manufacturing process contributed to the reported issue.No surgical notes were provided for the initial surgery, therefore it is not possible to assess the surgical technique used.Additionally, the received medical evidence does not confirm the reported event, since the health care professional could not identify the periprosthetic fracture on the provided x-rays.Given the complaint description and the available data, it is very likely that the reported issue is due to the fall injury of the patient, however a definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ALLOCLASSIC, SL STEM, UNCEMENTED, 3, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND 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: 15460586
• Report Number: 0009613350-2022-00485
• Device Sequence Number: 16873524
• Product Code: HSB
• UDI-Device Identifier: 00889024590250
• UDI-Public: (01)00889024590250(17)150430(10)2552033
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 2843
• Device Lot Number: 2552033
• 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: 09/03/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 52 KG