MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. G7 OSSEOTI 4 HOLE SHELL 54MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product was returned and evaluated.A visual examination of the returned product found a majority of the tyvek was previously removed and one corner of the tyvek was folded.The reported seal failure cannot be confirmed as the product was returned opened, and the blister flange exhibited full tyvek adhesive transfer.A sterility breach also cannot be confirmed as the product was returned opened.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.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

It was reported that the packaging appeared to not be glued correctly close to the corner, and the surgeon requested another implant.There was no patient involvement, no patient impact, and no surgical delay.No additional information.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 54MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16860545
• MDR Text Key: 314461611
• Report Number: 3007963827-2023-00112
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00887868355899
• UDI-Public: (01)00887868355899(17)320706(10)65451156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 110010245
• Device Lot Number: 65451156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1