MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER BIOMET ZB 12/14 COCR HD 36MM X +0; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: czech republic; 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 or Problem Description
It was reported that the sterile package cover was found opened and not secure.It was also reported that there was no patient involvement and no delay of surgery.Another implant was available to be used to finish surgery smoothly.No additional information was available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Product and product photos were returned and evaluated.A visual evaluation of the returned product and provided photos found that the outer sterile blister was cracked open.The inner sterile blister exhibited no damage and sterility was intact.Sterility had not been compromised.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.The reported event was not related to a combination of products; therefore, a compatibility review was not applicable.The condition of the device when it left zimmer biomet is considered conforming to specification.The reported issue was confirmed by evaluation of the provided photos and the returned product; however, sterility had not been compromised.The root cause of the reported event can be attributed to transit damage.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.

• Brand Name: ZIMMER BIOMET ZB 12/14 COCR HD 36MM X +0
• Common Device Name: PROTHESIS, HIP
• 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: 18586135
• Report Number: 0001822565-2024-00233
• Device Sequence Number: 15216296
• Product Code: LPH
• UDI-Device Identifier: 00889024498884
• UDI-Public: (01)00889024498884(17)331024(10)3173496
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K183457
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 802203602
• Device Lot Number: 3173496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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: Unknown