MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Model Number 5450-32-500

Device Problems Failure To Adhere Or Bond (1031); Loss of or Failure to Bond (1068)

Patient Problems Inflammation (1932); Not Applicable (3189); No Code Available (3191)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address tibial loosening at the bone to aseptic cement interface.Depuy cement manufacturer.Baseplate well fixed to cement.It was also reported that patient has high bmi and physician believes patient needed longer tibial stem, revised to attune revision rp.Doi: (b)(6) 2016, doi: (b)(6) 2018; left knee.

Manufacturer Narrative

Udi: ((b)(4).(b)(4 was added to capture medical device removal.

Event Description

Medical records alleges inflammation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.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 necessary.Device history lot
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> device history reviewed: no non-conformances on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report related to implant loosening.Total for lot number: 1 (b)(4).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 9.By product family: 19 (8x depuy cmw 1g, 10x depuy cmw 2g, 1x depuy cmw 3g).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: 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.Viewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found one additional related reports against the provided product code/lot code combination(s).A dhr review was conducted and no anomalies were found.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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 necessary.Update 13-july-2020: re-opened due to medical records received on june 17, 2019.

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7581706
• MDR Text Key: 110472183
• Report Number: 1818910-2018-61616
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• PMA/PMN Number: K061144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 5450-32-500
• Device Catalogue Number: 545032500
• Device Lot Number: 8159148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 10 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR