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

Model Number	94-0014
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	05/09/2022
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
Clinical adverse event received for scar tissue under the quadriceps tendon - feelings of popping and crepitus within the knee.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022.Date of event: (b)(6) 2022.(left knee) treatment: arthroscopy.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Based on provided xray images of the implants position, a presence of a clunk noise cannot be definitely confirmed.Depuy synthese 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 LT SZ 4
• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14591267
• Report Number: 1818910-2022-09995
• Device Sequence Number: 20184433
• Product Code: MBH
• UDI-Device Identifier: 10603295223405
• UDI-Public: 10603295223405
• 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: 2022
• Device Explanted Year: 2022
• 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): 06/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 94-0014
• Device Catalogue Number: 940014
• Device Lot Number: J6297Y
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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; MBT POR TIBIAL TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White