MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Operative notes (b)(6) 2022 indicate the patient experienced an inferior pole patella fracture/patellar tendon compromise.Due to this, the patient received a repair inferior pole of the patella fracture and patellar tendon deficiency and augmentation of repair with fresh frozen achilles allograft.Repair was performed in part by using #5 ti-cron wire stitch.(captured on (b)(4)).Operative notes (b)(6) 2022 indicate the patient experienced a retained broken tension band wire (ti-cron) in the right knee, status post extensor mechanism reconstruction and delayed and non-healing wound from the repair surgical procedure.Due to this, the patient received a surgical removal of tension band wire, excision of nonhealing wound, 7 cm with a primary suture repair and placement of a long leg cast.No implants were revised, copious irrigation was performed.No indication of complications.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : device associated with this report wasn't received for examination, however x-ray photos were provided.All available x-rays were reviewed, and it can't be determine any device related problem.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.

• Brand Name: SIG C/R POROCOAT FEM RT SZ 3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13890372
• Report Number: 1818910-2022-05316
• Device Sequence Number: 15034752
• Product Code: MBH
• UDI-Device Identifier: 10603295223474
• UDI-Public: 10603295223474
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K062654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: 94-0023
• Device Catalogue Number: 940023
• Device Lot Number: H65387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ3 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White