MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 VMP ENDURANCE 80G; BONE CEMENT : BONE CEMENT

Catalog Number 3172080

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/05/2018

Event Type  Death  

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 Description

Patient¿s condition was abruptly changed when the surgeon inserted the stem and cement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.The number of complaints received for this failure mode will continue to be monitored and product updates/recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.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 required.Device history lot: device history reviewed: 0 non-conformances on this lot number.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional reports, however it does not relate to a cardiovascular event.Total for lot number: 2 ((b)(4)).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 1.By product family: 2x vacu-mix plus endurance (1x 50g, 1x 80g).Device history batch: null.Device history review: null.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: VMP ENDURANCE 80G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw 46582
• 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, IN 19380-0988 ; 6103142063
• MDR Report Key: 8132990
• MDR Text Key: 129324620
• Report Number: 1818910-2018-77217
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 3172080
• Device Lot Number: 8513348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR