MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Joint Laxity (4526)
Date of Event	03/30/2021
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
(b)(6) 2021: clinical post-op visit, bilateral knee replacements: seen by physician's assistant in office.Patient presented with feeling of "giving out" and "tapping" in knees.In physical examination, the right knee demonstrated 2mm of varus and valgus laxity, which suggested global instability.The right knee was captured in (b)(4).The left knee was determined to have quadriceps weakness, requiring physical therapy only.Plan was for physical therapy on both knees, and to have patient return to be seen by attending physician, and discuss possible right knee revision to increase thickness of the tibial insert.Doi: (b)(6) 2020 date of event (onset): (b)(6) 2021 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.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11753526
• Report Number: 1818910-2021-09286
• Device Sequence Number: 16920276
• Product Code: JWH
• UDI-Device Identifier: 10603295231967
• UDI-Public: 10603295231967
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/16/2021

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: 96-0004
• Device Catalogue Number: 960004
• Device Lot Number: D19111929
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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: DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 10; DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 134