MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source : (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During the inspection of the kit in the zb spain warehouse, it has been detected that the piece is broken.No patient involved.No surgery occurred.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d4; g4; g7; h1; h2; h4 once the investigation has been completed, an additional follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product/provided pictures identified the device was returned with the strike plate fractured off of the handle.Item and lot numbers are confirmed to match the complaint.There is damage and wear on the device.The device was sent to sem for further analysis: xrf analysis confirmed the strike plate material to be consistent with 17-4 stainless steel alloy.The features of this fracture surface and mode align with those reported in a zrm, summary of failure analysis of shoulder impactor threaded strike-plates: the common failure mode for the shoulder impactors presented in this summary was a fast-brittle type tensile/bending overload failure of the strike plate¿s threaded section.Device history record (dhr) was reviewed and no discrepancies were found.Device has a potential field age of 3.5 years with an unknown number of uses.A definitive root cause cannot be determined.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: 25MM COMP RVS GLEN TRAY IMPTR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10308333
• MDR Text Key: 200845737
• Report Number: 0001825034-2020-02879
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

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 Model Number: N/A
• Device Catalogue Number: 405809
• Device Lot Number: 2923013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/04/2020; 11/04/2020
• Supplement Dates FDA Received: 08/04/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1