MAUDE Adverse Event Report: DEPUY CMW ¿ 9610921 SMARTSET GHV GENTAMICIN 40G; CEMENT / CEMENT ACCESSORY

Catalog Number 545035500

Device Problems Loss of or Failure to Bond (1068); Disassembly (1168); Fracture (1260)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Date 08/17/2010

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.(b)(4).

Event Description

New etq record created in order to update etq (legal system) complaint number wpc (b)(4).Reason for original complaint - litigation papers allege the bolt failed and fractured.Update: 6/21/2011 - received sticker pages from the legal department, which includes product code and lot information.Update: 08/21/2011 - revision operative report received and states disassociation between the femoral component and the femoral stem, as well as the bolt connecting the two had broken; the femoral component was grossly loose and with such disassociated from the femoral stem.Femoral stem and femoral component added to complaint.Dor: (b)(6) 2010.Update: 9/9/2015 - medical records received.After review of the medical records for mdr reportability, the cement is now being added for the grossly loose stem.Pain was also indicated in the revision operative note.The medical records also indicate there was a previous non-healing fracture of the upper femur that was cabled, the date and cause of the fracture is unknown at this time.The complaint was updated on: 10/7/2015.

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search on the provided (b)(4) gentamicin 40g (product code 545035500, lot number 2980992) found additional reports.A previous dhr review (b)(4) did not reveal any related manufacturing deviations or anomalies.A worldwide complaint database search found no other related incident(s) against the remaining product/lot combination(s) since release for distribution.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

Depuy still considers this investigation closed at this time.

Event Description

Update 2/29/2016 medical records received.Medical records reviewed for mdr reportability.There is no new additional information that would affect the existing investigation.The complaint was updated on: mar 15, 2016.

Manufacturer Narrative

No device associated with this report was received for examination.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.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.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 previous dhr review was performed as part of investigation performed in wpc 1609-2010.Review of the device history records did not reveal any related manufacturing deviations or anomalies.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW ¿ 9610921 ; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW ¿ 9610921 ; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5135567
• MDR Text Key: 27772834
• Report Number: 1818910-2015-32325
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 545035500
• Device Lot Number: 2980992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 88 KG