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

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Complaint sample was returned and reviewed against the reported event.Six boxes were returned and evaluated, noting the sterile barrier has been broken on three of the boxes.The other three remain intact.Dhr was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The investigation has concluded that the root cause of the reported event is likely to be damage during transit.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01297, 0001825034 - 2020 - 01300.
Event or Problem Description
It was reported that during stock investigation, it was found that the sterile packages were damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TAPERLOC FEMORAL STEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10314495
• Report Number: 0001825034-2020-01299
• Device Sequence Number: 11031402
• Product Code: LPH
• UDI-Device Identifier: 00880304517455
• UDI-Public: (01)00880304517455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: 51-149080
• Device Lot Number: 6196830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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