MAUDE Adverse Event Report: DEPUY IRELAND SMARTSET MV 40G - EO; CEMENT / CEMENT ACCESSORY

Catalog Number 3122040

Device Problems Device Slipped (1584); Unstable (1667); Malposition of Device (2616)

Patient Problems Fall (1848); Pain (1994); Swelling (2091); Osteolysis (2377)

Event Date 08/22/2016

Event Type  Injury  

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.Quantity: 2.

Event Description

Patient was revised to address instability.It was noted, the patient fell.Updated rec'vd 9/14/2016- clinical der states patient was revised to address instability.There is no new information at this time that would change the current mdr decision.Clinical information and comorbidities will be added to complaint.The complaint was updated on 9/18/2016.Update rec'd 9/21/2016: medical records received.After review of the medical records for mdr reportability, the medical records indicated the patient had pain, swelling, and instability before the dor.Patient did sustain a fall in (b)(6) 2015.Diagnostic imaging indicated no findings (loosening, osteolysis, or malpositioning).The patient indicated the patella was grinding, locking, and shifting.The patella wasn't revised on (b)(6) 2016.Depuy cement was used during the primary.All products are now being reported.This complaint was updated on: 10/14/2016.

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search on the provided smartset mv 40g - eo (product 3122040, lot number 3623617) found an additional report and a dhr review was conducted.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number (3623617).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.

• Brand Name: SMARTSET MV 40G - EO
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6031415
• MDR Text Key: 57513837
• Report Number: 1818910-2016-29562
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 3122040
• Device Lot Number: 3623617
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 86