MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 LATERALIZD HUM CUP DIA 36+6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number 4CHL636

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Septic Shock (2068); Joint Dislocation (2374); Not Applicable (3189)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Primary surgery was performed on (b)(6) 2005 for a glenohumeral arthrosis.Then the patient has been hospitalized on the (b)(6) 2018 with a septic shock.On the (b)(6) 2018 a removal surgery was performed.The stem appeared to be dislocated and with biofilm inside of the medullary canal.The glenosphere appeared to be dislocated as well and it presented infected material organized as a biofilm.

Manufacturer Narrative

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

• Brand Name: LATERALIZD HUM CUP DIA 36+6MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; b.p. 256; leeds 69801 ; UK 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7583453
• MDR Text Key: 110519595
• Report Number: 1818910-2018-61688
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295170471
• UDI-Public: 10603295170471
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4CHL636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Date Device Manufactured: 06/14/2005
• 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: 81 YR