MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL HIP STEM, UNCEMENTED, ø 22/225, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial right total hip arthroplasty in (b)(6) 2014 followed by a revision in (b)(6) 2015 due to loosening.Later on, (b)(6) 2023, underwent a second revision for metallosis and a fractured stem.Subsequently, on (b)(6) 2024, fell and experienced a femoral periprosthetic fracture.Approximately one month ago, underwent an additional procedure where a stable double plate osteosynthesis was performed.It is unclear at this time if implants were revised as no further details have been provided.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2.Report source: germany.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 a patient had an initial right total hip arthroplasty followed by a revision approximately 14 months later due to loosening.Later, approximately 8 years later, a second revision was performed for metallosis and a fractured stem.Subsequently, approximately 1 month later, the patient fell and experienced a femoral periprosthetic fracture and underwent an additional procedure where a stable double plate osteosynthesis was performed.It is unclear at this time if implants were revised as no further details have been provided.Diligence is complete and no further information on the reported event have been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d1, d4, g3, g4, g6, h2, h3, h6, h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history found no additional related complaints for this item.Based on the available information it can be concluded that the reported event is most likely due to the fall of the patient.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
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: zb 12/14 cocr hd 36mm x -3.5; item# 802203601; lot# 3151360; dural alpha insert neutr jj/36; item# 01.00013.710; lot# 3135805.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item.Based on the available information it can be concluded that the reported event is most likely due to the fall of the patient.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.

• Brand Name: WAGNER SL HIP STEM, UNCEMENTED, ø 22/225, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18730414
• Report Number: 0009613350-2024-00051
• Device Sequence Number: 20901949
• Product Code: LZO
• UDI-Device Identifier: 00889024593435
• UDI-Public: (01)00889024593435(17)260228(10)3064562
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 0100102222
• Device Lot Number: 3064562
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 06/07/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 89 KG