MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT SIZE G CEMENTED OPTION FEMORAL COMPONENT FEMORAL PLASTIC CAP; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, it was discovered that the inner packaging of the implant was damaged as it was cracked.There was no damage to the outer box, however, the two inner plastic shells protecting the implant were split.The sterility was questioned and another implant was used to complete the surgery.There was no surgical delay and no consequences for the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2 : foreign country : 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as this event is a duplicate event that was previously reported under mfr number 001822565-2023-01893.The initial report was forwarded in error and should be voided.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: LEFT SIZE G CEMENTED OPTION FEMORAL COMPONENT FEMORAL PLASTIC CAP
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17322576
• Report Number: 0001822565-2023-01903
• Device Sequence Number: 17520325
• Product Code: JWH
• UDI-Device Identifier: 00889024224841
• UDI-Public: (01)00889024224841(17)310515(10)64895267
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00599401791
• Device Lot Number: 64895267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose