MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/24/2018

Event Type  Injury  

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 Description

Medical records received 17 june 2019 and were reviewed 30 september 2019 for mdr reportability.On (b)(6) 2017, the patient underwent total left knee arthroplasty due to osteoarthritis and pain.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2018 the patient underwent a left knee revision due to loosening of the tibial component, and pain.The surgeon indicated the osteotome was used to slightly tap the tibial component and it came loose easily.He offered no complaints regarding the femoral component, though it was revised.The patella was not revised.The patient was implanted with depuy knee system and depuy cement x 2.There were no complications reported with the procedure.Doi: (b)(6) 2017; dor: (b)(6) 2018 (lt knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> 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
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> device history reviewed: one unrelated non-conformance on this lot number.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found additional reports, and they also related to implant loosening.Total for lot number: 3 (b)(4).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 95.By product family: 192 (66x smartset ghv, 126x smartset gmv).If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9213498
• MDR Text Key: 173208162
• Report Number: 1818910-2019-110904
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 8432627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 11/25/2019
• Supplement Dates FDA Received: 11/22/2019; 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR