MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN WAGNER TRAIL STEM; HIP INSTRUMENTS

Catalog Number UNKNOWN

Device Problem Separation Problem (4043)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign- switzerland.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during surgery, the surgeon was not able to remove a trial stem.Eventually, surgeon was able to remove the trial stem with the help of chisels and other instruments.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided.Visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records.Neither were provided.Device is used for treatment.Medical records were not provided.A definite root cause can not be identified.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 Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN WAGNER TRAIL STEM
• Type of Device: HIP INSTRUMENTS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 16129735
• MDR Text Key: 307908783
• Report Number: 0009613350-2023-00011
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose