MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL FEMORAL STEM PRESS-FIT COLLARLESS; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D11: trabecular metal femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 18 172 mm stem length cementless.D10: 00786401700 femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 17 172 mm stem length cementless 63207152, 00786401820 femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 18 172 mm stem length cementless 62721814.Further evaluation of the returned packaging for lot 63602616 determined sterility is considered breached.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues with the reported item and lot combination.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.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.This complaint was confirmed by evaluation of the provided photos and returned product.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
It was reported the product packaging was compromised.The seal was reported to be broken by the implant breaking or cracking the sterile packaging from the inside.There are no visible signs of damage in either direction of internal packaging.There was no patient involvement.

• Brand Name: TRABECULAR METAL FEMORAL STEM PRESS-FIT COLLARLESS
• Common Device Name: PROSTHESIS, HIPS
• 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: 20140618
• Report Number: 0001822565-2024-02837
• Device Sequence Number: 7417606
• Product Code: LPH
• UDI-Device Identifier: 00889024139350
• UDI-Public: (01)00889024139350(17)270331(10)63602616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00786401800
• Device Lot Number: 63602616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown