MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT OPTION SIZE G RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: france.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

It was reported that during the surgery, when implants were taken to the surgery table it was noted that the two rigid plastic packs inside were broken, split in two.As sterility was compromised the implant could not be used.There was a delay in surgery time.Procedure was completed using an alternate implant.

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.  visual evaluation of the provided photos and returned product found damage to the sterile blisters that is visually consistent with transit damage for this packaging configuration.The sterility has been breached.The complaint has been confirmed by evaluation of the provided photos and returned product.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history found no additional related issues for the reported part and part lot combinations.Medical records were not provided.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage.No actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  the product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

• Brand Name: FEMORAL COMPONENT OPTION SIZE G RIGHT
• Type of Device: PROSTHESIS, KNEE
• 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: 18317263
• MDR Text Key: 330362599
• Report Number: 3007963827-2023-00336
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060037
• 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,Followup
• Report Date: 02/06/2024

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: 00596401752
• Device Lot Number: 63936730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/05/2024; 02/01/2024
• Supplement Dates FDA Received: 01/30/2024; 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2019
• 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
• Patient Sex: Male