MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION, TRIAL STEM, DISTAL, 18; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source¿ italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during hip arthroplasty surgery, a wagner trial stem was selected.During this operation the interconnection screw between the metaphysis and the taproot was broken, making its removal difficult.The surgeon had to lengthen the incision and make a femoral resection to extract the trial stuck in the femur and then make a reduction and implant a longer stem.The surgical time increased by 90 minutes.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).  upon review of this complaint from an investigation perspective, it is considered that the wagner sl revision, trial stem, distal, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 0009613350 - 2023 - 00208.Given the above information, this product will now be considered an associated item.
Event or Problem Description
Upon review of this complaint from an investigation perspective, it is considered that the wagner sl revision, trial stem, distal, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 0009613350 - 2023 - 00208.

• Brand Name: WAGNER SL REVISION, TRIAL STEM, DISTAL, 18
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 16543924
• Report Number: 0009613350-2023-00114
• Device Sequence Number: 17723518
• Product Code: LZO
• UDI-Device Identifier: 00889024277847
• UDI-Public: (01)00889024277847(11)130719(10)13.866541
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/11/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00109.118
• Device Lot Number: 13.866541
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose