MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL AUGMENT HALF BLOCK RIGHT MEDIAL SIZE CD 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi: (b)(4).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
Device returned without packaging, packaging damage with sterility barrier potentially compromised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 visual examination of the returned product identified that the carton box is only damaged where it was opened.The bottom panel is torn and depressed down at the half-round cut-off used for easy opening where the tamper-proof seal was applied.No other damage was observed on the carton box.The carton box was returned opened, unwrapped, and containing only one patient label and the implant.The shrink-wrap, sterile cavities, tyvek lids, three patient labels, and ifu were not returned.Complaint is not confirmed.Device history record (dhr) review identified no deviations or anomalies during manufacturing.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.A definitive root cause cannot be determined.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: TIBIAL AUGMENT HALF BLOCK RIGHT MEDIAL SIZE CD 10 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9912416
• Report Number: 0001822565-2020-01250
• Device Sequence Number: 16999992
• Product Code: JWH
• UDI-Device Identifier: 00889024557352
• UDI-Public: (01)00889024557352
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 42555803410
• Device Lot Number: 64484549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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