MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3105040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Not Applicable (3189); No Code Available (3191)

Event Date 09/30/2018

Event Type  Death  

Manufacturer Narrative

(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

Death case.This case was reported from health authority.The patient was admitted to our hospital due to a left femoral trochanteric fracture and was sent to the operating room on (b)(6) 2018 at 8 a.M.For hip arthroplasty.Prosthesis was inserted after femoral resection, bone cement was implanted at 11 o'clock.At 11:15 a.M, the patient's heart rate decreased to 40 beats/min , blood pressure was not measured, pressor was given immediately, the patient¿s heart was stopped at 11:20, cardiopulmonary resuscitation, cardiac defibrillation, dexamethasone, epinephrine intravenous injection, etc.The patient's heartbeat and respiration did not recover and was declared dead at 2:04 p.M.No additional information can be provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the complaint states: ¿death case.This case was reported from health authority.The patient was admitted to our hospital due to a left femoral trochanteric fracture and was sent to the operating room on (b)(6) 2018 at 8 a.M.For hip arthroplasty.Prosthesis was inserted after femoral resection, bone cement was implanted at 11 o'clock.At 11:15 a.M, the patient's heart rate decreased to 40 beats/min , blood pressure was not measured, pressor was given immediately, the patient\2018s heart was stopped at 11: 20, cardiopulmonary resuscitation, cardiac defibrillation, dexamethasone, epinephrine intravenous injection, etc.The patient's heartbeat and respiration did not recover and was declared dead at 2: 04 p.M.No additional information can be provided.¿ retained powder and liquid samples of the complaint batch in question were obtained, conditioned to 23°c, and mixed in the laboratory in a beaker under ventilated, temperature and humidity-controlled conditions.Retained sample retest results: see attachment ¿(b)(4) retest results.Pdf¿.Tm-t150 - the mix was thin with the powder and liquid components combining as normal with a wet-out time of 5 seconds and a mean dough time of 3 minutes 37 seconds.The appearance and handling characteristics of the cement were as expected with all results obtained being within specification criteria.Tm-t062 - benzoyl peroxide = 1.633% w/w ¿ within specification.Tm-t220 ¿ dmpt content = 0.821% w/w - within specification.Tm-t109 ¿ powder ir scan = positive.Tm-t179 ¿ liquid ir scan = positive.No product problem or unusual observations were observed on the testing of the retained samples of this batch.Dva-107020-fde rev 9 was reviewed.Cardiac events including fatality as a possible outcome are included on line 76 during the bone cement curing phase.The risk is considered as low as possible and cannot be further mitigated (ifr).See attachment ¿(b)(4) extract from dva-107020-fde.Pdf¿.(b)(4) rev b was reviewed, and cardiovascular events are included in the adverse events section under the heading ¿serious adverse events, some with fatal outcome¿ 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.2700 units released.Lot expiry date: 30 september 2020.H10 additional narrative: corrected: h6 (patient).Patient code: removed not applicable code and replaced with no code available (3191) to capture insufficient information.

• Brand Name: SMARTSETGMV ENDURANCE GENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10276068
• MDR Text Key: 198880588
• Report Number: 1818910-2020-15898
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3105040
• Device Lot Number: 8657069C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTSETGMV ENDURANCE GENT 40G.; SMARTSETGMV ENDURANCE GENT 40G
• Patient Outcome(s): Death