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

Catalog Number 545050501

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670)

Patient Problems Pain (1994); Synovitis (2094); No Information (3190); No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Depuy synthes has been informed that the lot number is not available.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.

Event Description

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

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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.(b)(4) 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 (b)(6) 2019.The medical records received on (b)(6) 2019 were reviewed for mdr reportability on (b)(6) 2019.On (b)(6) 2016, the patient underwent a left knee revision due to pain, synovitis, and tibial malpositioning and loosening at the cement to implant interface.Two depuy cements were used during the primary operation.

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: a2 (dob), b5, d4(lot and expiry), g2 and h6 ( device code ).Corrected: a1.H6 patient code: no code available (3191) used to capture the surgical intervention.

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#: (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.Device history lot: device history reviewed: 2 unrelated non conformances on this batch.Micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found additional reports related to implant loosening total for lot number: 3 (com-270936, pc-000195755, pc-000223376).Complaints received by cmw in the last 12 months for this issue by product code: 129.By product family: 202 (69x smartset ghv, 133x smartset gmv).Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5742886
• MDR Text Key: 47971729
• Report Number: 1818910-2016-21990
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: PK081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 545050501
• Device Lot Number: 7786802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided; 07/24/2019; 02/21/2020
• Supplement Dates FDA Received: 07/06/2016; 07/30/2019; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VOIDED; VOIDED; VOIDED
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR