MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, TRIAL HUMERAL PE-INSERT, 36-6; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2 ¿ report source: poland.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 the procedure, it was noticed that a piece of the the trial humeral insert had fractured off.The broken piece was was located and discarded.No impact on patient was reported.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.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Four out of six flanks are broken off.The other surfaces of the item are inconspicuous.A review of the device manufacturing records identified a non-conformancy that could be related to the reported event.The parts were released into final stock as the deviations do not have a significant impact on the application.Also it was evaluated that there is no additional risk for the patient, user or third parties.Device manufacturing records were reviewed for the identified additional similar complaints found during the complaint history; however, none of these complaints showed a similar non-conformance.Therefore, the non-conformance can be rule out as definitive root case for this complaint.Device is used for treatment.Medical records were not provided.With the available information a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: ANATOMICAL SHOULDER, TRIAL HUMERAL PE-INSERT, 36-6
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17422553
• MDR Text Key: 320022473
• Report Number: 0009613350-2023-00423
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00889024287792
• UDI-Public: (01)00889024287792(11)210820(10)4504286844
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K193099
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.04239.720
• Device Lot Number: 4504286844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose