MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* FLUT TIB ROD 75X10MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-6410
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Customer is complaining the info on the label.The medical device is labelled as "cemented", but it is a device that will not be cemented.No surgical delay, no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device was returned as was a photograph for examination and further investigation confirms the label was correctly printed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination, but further investigation of the returned photograph confirms the label was correctly printed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10098483
• Report Number: 1818910-2020-12805
• Device Sequence Number: 2625758
• Product Code: JWH
• UDI-Device Identifier: 10603295216933
• UDI-Public: 10603295216933
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2020

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: 08/30/2020
• Device Model Number: 86-6410
• Device Catalogue Number: 866410
• Device Lot Number: E2AF54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/10/2020; 08/01/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/12/2020; 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1