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

Catalog Number 130760000

Device Problems Fracture (1260); Loss of Osseointegration (2408); Migration (4003)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 09/07/2018

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.(b)(6).

Event Description

Claim letter alleged pain.Radiographs revealed the screws holding the glenoid fractured causing the component to migrate.

Manufacturer Narrative

Pc-(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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, will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).

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).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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.

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

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b7, d2b, d4 (procode,lot,expiration,udi), d11, e1, g5, h4 and h6 (patient).Corrected: d1, d2, d3, g1 and g2.Removed: h6 (fracture) as device code.No code available (3191) is used to capture device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103728552
• MDR Report Key: 7927695
• MDR Text Key: 122447456
• Report Number: 1818910-2018-71094
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 130760000
• Device Lot Number: 5297634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 01/04/2019; 04/02/2019; 06/12/2019; 04/15/2019; 08/18/2020; 12/07/2021
• Supplement Dates FDA Received: 10/18/2018; 01/04/2019; 04/04/2019; 06/12/2019; 12/27/2019; 09/03/2020; 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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
• Treatment: DXTEND GLENOSPHERE STD D38MM; DXTEND MOD CENT EPI 1 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND STAND PE CUP D38 +3MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White