MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE PRIMARY FEMORAL; PROSTHESIS, HIP

Catalog Number	51-101070
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hole in the packaging.There was no patient involvement.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.The following sections were corrected: d1.-visual evaluation of the provided photos identified damage to the sterile packaging (pouch).Sterility has been compromised.The outer carton exhibits damage as well.As the stem has punctured the outer carton, the stem has punctured the blister as well, which is not depicted in the provided photos.-review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.-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 and a packaging design issue.-the reported event has been confirmed by evaluation of the provided photos.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 or Problem Description
No further information is available at the time of this report.

• Brand Name: TAPERLOC COMPLETE PRIMARY FEMORAL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19690461
• Report Number: 0001825034-2024-01792
• Device Sequence Number: 7936172
• Product Code: KWA
• UDI-Device Identifier: 00880304489769
• UDI-Public: (01)00880304489769(17)260314(10)3735245
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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 Expiration Date: 03/14/2026
• Device Catalogue Number: 51-101070
• Device Lot Number: 3735245
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown