MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, SCREW FOR TRIAL STEM; WAGNER CONE PROSTHESIS SYSTEM

Model Number N/A

Device Problems Misassembled (1398); Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: wagner cone prosthesis, screw for trial stem; catalog#: 01.00569.001; lot#: unknown.Arcos 18x190mm spl tpr dist m; catalog#: 11-300918; lot#: 032250.Arcos con sz a hi 70mm m sz a; catalog#: 11-301331; lot#: 238700.Wagner cone prosthesis, trial stem, distal, 20; catalog#: 01.00569.120; lot#: unknown.Wagner cone prosthesis, trial stem, proximal, 125, 20; catalog#: 01.00569.220; lot#: unknown.Wagner cone prosthesis, trial stem, proximal, 125, 21; catalog#: 01.00569.221; lot#: 13821209.Wagner cone prosthesis, 125, uncemented, 20, taper 12/14; catalog#: 01.00561.220; lot#: 3041065.Therapy date: unknown.The manufacturer received other source of documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

During surgery, the surgeon reamed a 20x125 stem and put together the trial.Since the trial screw were cross threaded, he implanted the real stem without trialing.As the stem sat too low, he explanted it and reamed up to 21 but he could not trial again due to another cross threaded screw in the trial.The surgery was completed using a longer arcos stem.Surgery was delayed for 45 minutes.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.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that during an initial total hip arthroplasty with a wagner cone system on (b)(6) 2021, the surgeon reamed for a 20x125 stem.During assembly of the trial stem, the screw cross threaded.Therefore, the surgeon implanted the final wagner cone stem without trailing.As the wagner cone stem sat too low, the stem was removed and the femoral canal was reamed up to 21.Trailing was again not possible due to another cross threaded screw in the trial stem.Eventually, the surgeon used a longer arcos stem to complete the surgery.The surgery was delayed for 45 minutes.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the wagner cone prosthesis 20x125 and the wagner proximal trial stem 21x125 with mounted trial screw were received.The wagner stem has some nicks on the shoulder next to the impaction hole and on the taper.The labeling on the proximal trial stem is slightly faded but still legible.In addition, the proximal trial stem also has indents on the shoulder.The trial screw has been inserted obliquely into the proximal trial stem.The threads are deformed and jammed together.The trial stem of size 20 and the trial screw, which were used to prepare the femoral canal for the returned wagner cone prosthesis of size 20, were discarded and have therefore not been returned.Review of product documentation: device purpose: all involved devices are intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr: no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that during an initial total hip arthroplasty with a wagner cone system on (b)(6) 2021, the surgeon reamed for a 20x125 stem.During assembly of the trial stem, the screw cross threaded.Therefore, the surgeon implanted the final wagner cone stem without trailing.As the wagner cone stem sat too low, the stem was removed and the femoral canal was reamed up to 21.Trailing was again not possible due to another cross threaded screw in the trial stem.Eventually, the surgeon used a longer arcos stem to complete the surgery.The surgery was delayed for 45 minutes.The quality records of all involved devices with known reference and lot number, 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 visual examination, the reported jamming of the trial screw in the proximal trial stem can be confirmed.The examination revealed that the trial screw was screwed in at an angle, resulting in deformation of the threads and jamming of the parts.Therefore, the cause of the jamming is the oblique insertion of the trial screw into the proximal trial stem.The cause of the too deep position of the wagner cone prosthesis can be attributed to an improper preparation of the femoral canal and/or the missed trailing.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).

Event Description

No change to previously reported event.

• Brand Name: WAGNER CONE PROSTHESIS, SCREW FOR TRIAL STEM
• Type of Device: WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11337364
• MDR Text Key: 242390258
• Report Number: 0009613350-2021-00076
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024282339
• UDI-Public: 00889024282339
• Combination Product (y/n): N
• PMA/PMN Number: K113556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00569.001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization