MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 265; WAGNER SL REVISION STEM LATERAL AND WAGNER CONE PROSTHESIS SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: wagner sl revision, trial stem, proximal, l 265; item# 0100109803; lot# unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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 surgery the screw that attaches the proximal trial to the distal trail was fractured.The distal portion remained stuck in the femoral canal which was removed successfully after 45-mins.A final wagner 15 x 265 stem was implanted and the femur wired shut.The delay of 60-mins was noted to remove the broken trial instrument and close the femur.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that during a right hip surgery on (b)(6) 2020, the screw connecting the proximal to the distal trial stem broke after numerous mallet strikes.The distal trial stem remained stuck in the femoral canal and could only be removed after 45 minutes leading to a total surgical delay of 60 minutes.A wagner 15 x 265 stem was implanted and the femur stabilized with cerclage wires.Review of received data: no medical records such as operative reports or intraoperative images have not been received.Product evaluation: visual examination: the proximal as well as the distal wagner trial stem and the screw for the trial stems were returned for examination.The proximal wagner trial stem is labeled size 265.The stem has some fine scratches, a slightly worn thread on the proximal shoulder, and an indented edge on the taper.The distal wagner trial stem is labeled diameter 15.The stem shows extensive damage and deformation in the proximal third of the stem.Parts of the four flanks are damaged, deformed or completely sheared off.In addition, there are countless deep scratches and indentations.A drill hole has been drilled into the stem in order to remove the stuck trial stem.The broken screw is still visible in the proximal screw hole.The remaining screw has a local constriction, which is visible as a reduction in cross-section.The separate screw is labeled size 265.There is clearly visible fracture constriction (reduced cross-sectional area of screw diameter) in the fracture area.In addition, circumferential indents are visible near the fracture area.See attached images.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during a right hip surgery on (b)(6) 2020, the screw connecting the proximal to the distal trial stem broke after numerous mallet strikes.The distal trial stem remained stuck in the femoral canal and could only be removed after 45 minutes leading to a total surgical delay of 60 minutes.A wagner 15 x 265 stem was implanted and the femur stabilized with cerclage wires.Based on the visual examination, the reported event can be confirmed.The examination revealed a ductile fracture with pronounced fracture necking of the trial screw connecting the distal to the proximal wagner trial stem.No visible macroscopic defect was found that could have caused the fracture.In addition, the extensive damage to the distal stem suggests that the distal stem was severely jammed in the femoral canal.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).Possibly, the distal wagner trial stem jammed in the femoral canal, which resulted in higher than expected forces acting on the trial screw when trying to remove the mounted trial stem with several hammer blows, causing the screw to break.However, an exact cause could not be found.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 (b)(4).The following reports are associated with this event: 0009613350-2020-00591-1.
Event or Problem Description
Investigation has been completed.

• Brand Name: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 265
• Common Device Name: WAGNER SL REVISION STEM LATERAL AND WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11026032
• Report Number: 0009613350-2020-00592
• Device Sequence Number: 667646
• Product Code: LZO
• UDI-Device Identifier: 00889024277977
• UDI-Public: 00889024277977
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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: 01.00109.806
• Device Lot Number: 11.682244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 05/31/2021
• 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