MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR 123 FEMORAL STEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 that during inspection of circulated stock, the sterile packaging was found damaged.There was no patient involvement.No further information has been provided.
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.Visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister).For lot 7089480, sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 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 returned product and provided photos.The 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
No further information is available at the time of this report.

• Brand Name: TAPERLOC COMPLETE XR 123 FEMORAL STEM
• 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: 20077847
• Report Number: 0001825034-2024-02094
• Device Sequence Number: 12677977
• Product Code: LPH
• UDI-Device Identifier: 00880304517158
• UDI-Public: (01)00880304517158(17)310928(10)7089480
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• 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): 12/20/2024

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: 51-105140
• Device Lot Number: 7089480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown