MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0082
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2019, the patient received a second left knee revision to address pain, instability, removal of fibrous tissue, and patellar tendon repair.All products were revised with the exception of the patellar component, which was retained.The patient was revised with competitor femoral component and universal sleeve, depuy tibial tray, stem, and insert, and depuy cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017 (patella), doi: (b)(6) 2018 (competitor cement, insert, tibia and femur - captured in (b)(4)), dor2: (b)(6) 2019, left knee.
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 at this time.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).A manufacturing records evaluation (mre) was not performed.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12010174
• Report Number: 1818910-2021-12813
• Device Sequence Number: 3304036
• Product Code: JWH
• UDI-Device Identifier: 10603295232490
• UDI-Public: 10603295232490
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 96-0082
• Device Catalogue Number: 960082
• Device Lot Number: HX2856
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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: ATTUNE MEDIAL DOME PAT 35MM; PFC* MOD + TIB TRAY SZ 2.5; PFC*SIGMA TC3 FEM LEFT SZ3; PFC*SIGMA TC3 INS 20MM,SZ2.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 115X16MM FLUTED; ZIMMER PALACOS BONE CEMENT; ZIMMER PALACOS BONE CEMENT; ATTUNE MEDIAL DOME PAT 35MM; PFC* MOD + TIB TRAY SZ 2.5; PFC*SIGMA TC3 FEM LEFT SZ3; PFC*SIGMA TC3 INS 20MM,SZ2.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 115X16MM FLUTED; ZIMMER PALACOS BONE CEMENT; ZIMMER PALACOS BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR