MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Catalog Number 130760138

Device Problem Disassembly (1168)

Patient Problem Pain (1994)

Event Date 01/03/2018

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.

Event Description

Der states that the patient complained of pain.The baseplate of the delta extend reverse radiographically appeared to be placed too far superior.It also appears that the glenosphere was not seated all the way.While in the shoulder it was evident that the ball was loose and spinning on the baseplate as though it had never been tightened enough for the morse taper to engage.The surgeon decided that the best thing for this patient was to put in anew eccentric 38 glenosphere and remove the original 38 standard that was loose.There was noted blackened tissue cause from the ball spinning around the base plate.He encourage the surgeon to remove the baseplate and put in a new one because of damage that may been created on the baseplate that might inhibit a good taper lock with the new ball.He understood my concerns but decided against changing the baseplate.We just did a glenosphere/poly swap.It was also reported that there was a bone/implant loosening interface.Doi: (b)(6) 2016, dor: (b)(6) 2018, unknown shoulder.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 130760138, lot number 5255888.Device history review: the dhr analysis of the returned product batch shows an initial conformance of this product regarding its specification.For this batch, there was no deviation or non-conformance.This batch was manufactured in october 2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: DXTEND GLENOSPHERE STD D38MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedics drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7218925
• MDR Text Key: 98225304
• Report Number: 1818910-2018-52066
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760138
• Device Lot Number: 5255888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Date Device Manufactured: 10/01/2015
• 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