MAUDE Adverse Event Report: DEPUY CMW 9610921 SMARTSET GMV 40G US EO; CEMENT / CEMENT ACCESSORY

Catalog Number 545050501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Information (3190); No Code Available (3191)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.See report for any product information received.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

Patient was revised to address tibial loosening at the cement/implant interface.Depuy cement was used.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Qty 2.(b)(4).

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec'd 01/15/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records upon revision there was a lytic area on the patella.At this time the patient's patella and insert are being reported.The complaint was updated on: 01/28/2016.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Dr-002788 has been undertaken to investigate further.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update: medical records received on (b)(6) 2020 were reviewed on 24 jan 2020 by a clinician to identify patient harms/product issues.Primary operative notes on (b)(6) 2012 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The patella was resurfaced and depuy cement x2 was utilized.The surgery was completed without indication of complication by the surgeon.Revision operative notes on (b)(6) 2015, indicate the patient received a left total knee revision due to pain, loose tibial component and lytic areas around the patella.There were no allegations of deficiency against the femoral component.The patella was revised.Depuy products including cement x2 were utilized at the revision.The surgery was completed without indication of complication by the surgeon.

Manufacturer Narrative

Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.  h10 additional narrative:   added: b5, d11, h6 (no code available (3191) is used to capture the surgical intervention and medical device removal).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).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.

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 review of the device manufacturing records (dhr) was already performed as part of this investigation.Please see the attached associated complaint for those results.Details for gentamicin component of combination product: dmf# - 13704 , trade name ¿ gentamicin sulphate , active ingredient(s) ¿ gentamicin sulphate , dosage form - powder , strength ¿ 1.0g active in our cements.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW 9610921; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 5242728
• MDR Text Key: 31827494
• Report Number: 1818910-2015-35669
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PK081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 3434421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE PS FEM LT SZ 5 CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 118