MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 MP SP T1 PPS HO 7X99; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during incoming inspection at zb warehouse in japan a team member found hair like debris in the sterile package.No patient involvement.
Additional Manufacturer Narrative
Product was returned and evaluated.A visual evaluation of the returned product found foreign debris inside the sealed sterile packaging.This issue was confirmed through evaluation of the returned product.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The reported event was not related to a combination of products; therefore, a compatibility review was not applicable.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device was likely non-conforming to specification when it left zimmer biomet.The root cause of the reported event was operator error during inspection of the packaging for foreign materials.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 event information is available at the time of this report.

• Brand Name: TLOC 133 MP SP T1 PPS HO 7X99
• Common Device Name: PROTHESIS, 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: 17305005
• Report Number: 0001825034-2023-01590
• Device Sequence Number: 7261273
• Product Code: KWA
• UDI-Device Identifier: 00880304513013
• UDI-Public: (01)00880304513013(17)330113(1)73656811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-109070
• Device Lot Number: 7365811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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