MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA CR150 CEM SZ 3 LT; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-20-300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
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
Knee revision all hardware was removed and replaced.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4) is being retracted as it was submitted in error.There are no allegations of patient consequence or injury, or device malfunction, that are related to depuy devices or procedure.

• Brand Name: SIGMA CR150 CEM SZ 3 LT
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11807772
• Report Number: 1818910-2021-10036
• Device Sequence Number: 14311775
• Product Code: JWH
• UDI-Device Identifier: 10603295074861
• UDI-Public: 10603295074861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 1960-20-300
• Device Catalogue Number: 196020300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIG HP FBT TRAY TRIAL SIZE 2.5; SIGMA CR150 CEM SZ 3 LT; SIGMA CURVED SZ 2.5 10MM TIB.I; SIG HP FBT TRAY TRIAL SIZE 2.5; SIGMA CR150 CEM SZ 3 LT; SIGMA CURVED SZ 2.5 10MM TIB.I
• Patient Age: 51 YR