MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA A/P CVD TB 8MM,SZ 4; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-0650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/11/2012
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
Clinical adverse event received for infection - deep.Event is serious and is considered severe.Event is definitely related to both device and procedure.Date of implantation: (b)(6) 2011, date of event (onset): (b)(6) 2012; (left knee).Treatment: knee revised on (b)(6) 2012, with removal of all depuy implants and placement of an antibiotic spacer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11373557
• Report Number: 1818910-2021-03762
• Device Sequence Number: 934712
• Product Code: JWH
• UDI-Device Identifier: 10603295233527
• UDI-Public: 10603295233527
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K971189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96-0650
• Device Catalogue Number: 960650
• Device Lot Number: FL1AK4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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: PFC*SIGMA A/P CVD TB 8MM,SZ 4; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET MV 40G - EO; PFC*SIGMA A/P CVD TB 8MM,SZ 4; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 109