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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported when the sterilized packaging of this shell was opened, it was reported that many water droplets were attached to the inside of the silver pouch.There were many drops of water on the transparent plastic bag.No additional information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d10, g4, h2, h3, h6.Reported event was confirmed by visual examination of the device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the provided pictures identified water droplets but it was not possible to evaluate whether those droplets are inside or outside the plastic bag containing the implant.The photographed bag is outside of the foil pouch and is unwrapped/opened.No signs of water could be identified in the provided picture showing the inside of the foil pouch.The product was returned with all sterile barriers opened.The implant was returned in the silver pouch within the open cavity within the carton.No water, condensation, moisture, or water stains were present on the returned implant or on the packaging materials at the time of evaluation.No other damage was noted.Complaint is confirmed from a provided picture.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product and the dhr review.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: SHELL WITH MULTI HOLES POROUS 50 MM O.D. SIZE HH
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10501727
• Report Number: 0001822565-2020-03148
• Device Sequence Number: 3182741
• Product Code: LPH
• UDI-Device Identifier: 00889024151352
• UDI-Public: (01)00889024151352
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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 Expiration Date: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875705002
• Device Lot Number: 64630004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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