MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEM EXTENSION SHARP FLUTED LONG 19MM DIA X 130MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 with packaging damage and sterility barrier compromised.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample wa evaluated and the reported event was confirmed.Visual inspection of the returned products found to exhibit damage to the cartons, outer blisters are cracked, and inner blisters are exhibit stress marks.Sterility has been compromised.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the product when it left zimmer biomet control was conforming to specifications.The root cause is attributed to transit damage.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.

• Brand Name: STEM EXTENSION SHARP FLUTED LONG 19MM DIA X 130MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10778215
• Report Number: 0002648920-2020-00486
• Device Sequence Number: 11034861
• Product Code: JWH
• UDI-Device Identifier: 00889024221376
• UDI-Public: (01)00889024221376
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598801619
• Device Lot Number: 63391212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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