MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 LATERALIZD HUM CUP DIA 36+3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number	4CHL336
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Reason for revision: pain, lose and broken glenoid implants.Patient presented with pain.X-rays confirmed lysis of all glenoid components as well as one broken screw.Surgeon believes a fall some years ago that fractured the diaphysis might be responsible for misalignment of the humerus that is responsible for the lose glenoid components.All glenoid components were removed and a cta head was placed on the humeral component to facilitate with articulation in the joint.
Additional 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.
Event or Problem Description
Additional information received.The affected side involved was right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
Additional information received stated that the metaglene component loosened on the glenoid surface and the inferior screw was broken.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

• Brand Name: LATERALIZD HUM CUP DIA 36+3MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10032879
• Report Number: 1818910-2020-11794
• Device Sequence Number: 3117260
• Product Code: KWS
• UDI-Device Identifier: 10603295170457
• UDI-Public: 10603295170457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 4CHL336
• Device Catalogue Number: 4CHL336
• Device Lot Number: 2317259
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2020
• Supplement Date Received by Manufacturer: 05/08/2020; 05/20/2020; 08/03/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/12/2020; 05/27/2020; 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLENOID DIA 36; LATERALIZD HUM CUP DIA 36+3MM; METGLNE SCRW DIA 4.5X18MM SPH; METGLNE SCRW DIA 4.5X30MM SPH; METGLNE SCRW DIA 4.5X36MM THRD; METGLNE SCRW DIA 4.5X42MM THRD; STANDARD METAGLENE V3.2; GLENOID DIA 36; LATERALIZD HUM CUP DIA 36+3MM; METGLNE SCRW DIA 4.5X18MM SPH; METGLNE SCRW DIA 4.5X30MM SPH; METGLNE SCRW DIA 4.5X36MM THRD; METGLNE SCRW DIA 4.5X42MM THRD; STANDARD METAGLENE V3.2
• Outcome Attributed to Adverse Event: Required Intervention