MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET MV 20G - EO; BONE CEMENT : BONE CEMENT

Model Number	3122-020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Osteolysis (2377); Unspecified Tissue Injury (4559)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Patient received a left attune knee to treat degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a left knee revision to address pain, osteolysis, tibial insert wear, tibial bone injury, tibial tray migration, and tibial tray loosening at the cement to implant interface.The surgeon noted the removal of fibrinous tissue as well as removal of meniscus of tissue that had developed around the poly patella component.The poly patella component was intact with very little wear and was retained.The tibial insert, tibial tray, and femoral component were revised.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2014, dor: (b)(6) 2020, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a device history record (dhr) review was conducted for product no.3122020 & lot no.3620326 previously on legacy (b)(4).No non conformances were found on this batch.Final micro and sterility tests were passed.

• Brand Name: SMARTSET MV 20G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13170125
• Report Number: 1818910-2022-00222
• Device Sequence Number: 13894422
• Product Code: LOD
• UDI-Device Identifier: 10603295168362
• UDI-Public: 10603295168362
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2022

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 Expiration Date: 05/31/2015
• Device Model Number: 3122-020
• Device Catalogue Number: 3122020
• Device Lot Number: 3620326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/20/2022; 02/03/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/24/2022; 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• 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: ATTUNE FB PS INSRT TR SZ6 5MM; ATTUNE FB PS INSRT TR SZ6 5MM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE PS FEM LT SZ 5 NAR CEM; SMARTSET MV 20G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female