MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 190; FEMORAL STEM PROSTHESIS TRIAL

Model Number N/A

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.As no lot number was provided, the device history records could not be reviewed.The manufacturer did not yet receive the device, however it is indicated by complainant that it will be returned for investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Event happened during the surgery.It was noticed that while reaming the trail got stuck in the canal.A slap hammer was used to remove the trial.The neck and the locking screw fractured in the trial.There is no surgical delay.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.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.D11 concomitant medical products wagner sl revision, trial stem, proximal, l 190 ref:0100109810; lot: 15.165524; wagner sl revision, trial stem, distal, 17 ref:0100109117; lot: 4502073x42.Event description: it was reported that during surgery while reaming the trial got stuck in the canal.A slap hammer was used to remove the trial.The neck and locking screw fractured in the trial.Harm: s1 - no patient, user, or other stakeholder harm.Hazardous situation: instrument breaks, diverges or becomes damaged and non-functional during surgical procedure.Review of received data: due diligence: further due diligence to support the conclusion was completed and documented in diligence log dl1609030.Product evaluation: visual examination: the proximal and distal wagner trial stems have been received.The fractured screw is stuck in the trial stems.The visual examination confirms the reported event.There are severe deformations, indentations and scratch marks on the outer surface of the distal trial stem.In addition, some fins were deformed.A hole has been drilled into the body ca.1 cm below the proximal edge of the distal trial stem, most likely to facilitate explantation.The distal part of the screw is stuck in the distal trial stem and therefore not available for further investigation.The proximal trial stem shows normal signs of use and a few scratches, most likely resulting from explantation after breakage of the screw.The proximal part of the fractured screw is still stuck in the proximal trial stem and therefore not available for further investigation.The nature of the fracture could not be determined.See images attached.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Conclusion: it was reported that during surgery while reaming the trial got stuck in the canal.A slap hammer was used to remove the trial.The neck and locking screw fractured in the trial.Based on the investigation the reported event can be confirmed.The investigation did not identify a non-conformance or a complaint out of box (coob).As the screw is still stuck in the trial stems the nature of the fracture could not be determined.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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).

• Brand Name: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 190
• Type of Device: FEMORAL STEM PROSTHESIS TRIAL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11929938
• MDR Text Key: 254266370
• Report Number: 0009613350-2021-00251
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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: 01.00109.809
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE FIELD H10
• Patient Outcome(s): Hospitalization