MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND SCREW LOCK D4.5X24MM; SHOULDER OTHER IMPLANT

Catalog Number 130790024

Device Problem Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Paresis (1998)

Event Date 08/23/2016

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

Patient was revised to address an infection.Update aug 7, 2017: claim letter received.This complaint was updated on.Update 8-7-2017: claim letter has been reviewed.The document indicates that approximately two months post primary reverse shoulder replacement the patient had his shoulder was not functioning as intended and was manipulated by his surgeon to allow him to use his shoulder during physical therapy.Shortly thereafter, the patients shoulder became infected for which he received antibiotic therapy.At time of revision due to infection, a biopsy of the tissue surrounding the previous location of the artificial shoulder was taken and revealed foreign fibers, including metal, within the tissue.The total reverse shoulder was explanted upon revision and antibiotic spacers were placed.Once the infection cleared an unknown shoulder replacement system was re-implanted.The claim letter also indicates that the patient is still having pain.Please take note, it is unknown if the current shoulder replacement is depuy products.Reportability has been updated.Updated 8-28-2017.

Manufacturer Narrative

(b)(4).Investigation summary: the received device was evaluated by the manufacturer.The dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.There was no deviation or non-conformance.Corrective action was not indicated.Device history lot: product code 130790024, lot number 5261586.Device history review:the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.There was no deviation or non-conformance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update 11-20-2017: legal medical records have been reviewed.Primary operative notes (b)(6) 2016 indicate the patient received a reverse shoulder replacement due to cuff tear arthropathy, should shoulder.The procedure was completed without indication of complication by the surgeon.Operative notes (b)(6) 2016 indicate the patient received a removal of left reverse total shoulder replacement, irrigation, debridement and placement of competitor antibiotic spacer and beads due to infected left total shoulder replacement.Upon incision, the surgeon noted a grey metallic appearance which he stated to look like metal wear.The procedure was then completed without indication of complication by the surgeon.Operative notes (b)(6) 2016 verify a competitor product shoulder construct was re-implanted after antibiotic spacer removal.There has been no new information provided that would impact mdr reportability.Updated 12-18-2017.

• Brand Name: DXTEND SCREW LOCK D4.5X24MM
• Type of Device: SHOULDER OTHER IMPLANT
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 6846481
• MDR Text Key: 85078436
• Report Number: 1818910-2017-24144
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027836
• UDI-Public: 10603295027836
• 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,Followup,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 130790024
• Device Lot Number: 5261586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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
• Patient Age: 75 YR