MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	130710000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Patient had primary reverse shoulder arthroplasty on the (b)(6) 2015.Approximately three months ago the patient started experiencing pain in the operative shoulder.He approached the treating surgeon and surgeon confirmed aseptic loosening of the humeral component.Revision surgery performed on (b)(6) 2020 at (b)(6) hospital.Confirmed during surgery that humeral component was loose as it could be removed without the aid of instruments.
Additional 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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: DXTEND MODULAR HUM STEM D10 HA
• Common Device Name: 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
• MDR Report Key: 10145416
• Report Number: 1818910-2020-13680
• Device Sequence Number: 19629385
• Product Code: KWS
• UDI-Device Identifier: 10603295027126
• UDI-Public: 10603295027126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 130710000
• Device Catalogue Number: 130710000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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: DXTEND GLENOSPHERE STD D38 MM; DXTEND MOD CENT EPI 1 HA; DXTEND SCREW NO LOCK D4.5X18 MM; DXTEND STAND PE CUP D38 +3 MM; DXTEND GLENOSPHERE STD D38 MM; DXTEND MOD CENT EPI 1 HA; DXTEND SCREW NO LOCK D4.5X18 MM; DXTEND STAND PE CUP D38 +3 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR