MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 STAND CUP TRIAL D42 +3MM; EXTREMITY INSTRUMENTS : HUMERAL TRIALS

Catalog Number 230742403

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the humeral cup trials have shaving of plastic coming off of them.Had to open three different trays for case.All went well and nothing left in patient.

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.

Manufacturer Narrative

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.Product complaint # : (b)(4).Investigation summary : examination of the returned device revealed heavy wear, gouging and scratching.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 : null 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: STAND CUP TRIAL D42 +3MM
• Type of Device: EXTREMITY INSTRUMENTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curi; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8269035
• MDR Text Key: 133845750
• Report Number: 1818910-2019-81858
• Device Sequence Number: 1
• Product Code: LHX
• UDI-Device Identifier: 10603295115885
• UDI-Public: 10603295115885
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230742403
• Device Lot Number: 5244484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 01/31/2019
• Patient Sequence Number: 1
• Patient Age: 67 YR