MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS STD/STD+ SPACER BLOCK; KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS

Model Number	2267-27-000
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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
Broken and worn lcs milestone standard spacer paddle.No debris occurred.

• Brand Name: LCS STD/STD+ SPACER BLOCK
• Common Device Name: KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11266075
• Report Number: 1818910-2021-02255
• Device Sequence Number: 3132101
• Product Code: HWT
• UDI-Device Identifier: 10603295108764
• UDI-Public: 10603295108764
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 2267-27-000
• Device Catalogue Number: 226727000
• Device Lot Number: J1105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1