MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY SHELL WITH CLUSTER HOLES POROUS 50 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products:: unknown liner, unknown stem, unknown head.Foreign country: (b)(6).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 that during surgery, it was found that the inner packing was damaged and other impurities were on the surface of product.A second device was used to complete the surgery.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified a trilogy fiber metal shell that was returned with packaging content.As returned, the foil pouch has been cut open and the shell has been removed from the pouch.The poly bag that the shell is placed in prior to being put in the foil pouch is missing.The inner cavity and tyvek lid was not returned.Brown colored debris is seen in the foil pouch.The acetabular shell shows similar colored debris embedded in the fiber metal.Under magnification the debris exhibits a mold like appearance.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 available at the time of this report.

• Brand Name: TRILOGY SHELL WITH CLUSTER HOLES POROUS 50 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8961116
• Report Number: 0001822565-2019-03816
• Device Sequence Number: 14097241
• Product Code: LPH
• UDI-Device Identifier: 00889024150157
• UDI-Public: 00889024150157
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 00875305001
• Device Lot Number: 63941033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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
• Patient Age: 48 YR