MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MODULAR HUM STEM D12 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number 130712000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/25/2019

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

1st stage revision shoulder arthroplasty.Approximately 9 month history of discomfort and reduced range of motion.Serum clinical markers, as stated by dr.(b)(6) indicated infection in prosthetic shoulder joint.All prosthesis removed.Humeral osteotomy required to removed well fixed stem.Multiple tissue specimens taken.Turbid fluid aspirated from joint prior to joint being opened.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND MODULAR HUM STEM D12 HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• 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 INTERNATIONAL LTD. 8010379; st. anthony's rd; b.p. 256; leeds 69801 ; UK 69801
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 9194252
• MDR Text Key: 168623157
• Report Number: 1818910-2019-110052
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027171
• UDI-Public: 10603295027171
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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 Catalogue Number: 130712000
• Device Lot Number: 5241248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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
• Patient Age: 70 YR