MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.The device showed damage to the outer and inner cavities (fracture, stress marks).The outer cavity of one of the two units from lot #64311677 is fractured and therefore its sterility is compromised.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.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
It was reported during inspection at the (b)(6) warehouse that the package was damaged.No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10218227
• Report Number: 0001822565-2020-02235
• Device Sequence Number: 3233649
• Product Code: LPH
• UDI-Device Identifier: 00889024131750
• UDI-Public: (01)00889024131750(17)290531(10)64311677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: 00771100910
• Device Lot Number: 64311677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/01/2020
• 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