MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MBLOC HUM EPI 1 D8 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	130708100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/24/2020
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
Revision of delta xtend reverse shoulder replacement.Pt had a fall and was experiencing instability and pain.X-ray showed displacement of stem.All implants removed from pt, no implants placed back in.If other, describe: reverse shoulder replacement revision, did the patient experience a post-op device malfunction? no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing?yes, did the patient require revision surgery or hardware removal? yes, facility name of original implant: (b)(6) hospital, was device explanted? true, hardware/explant removal due to: pt had a fall, displaced the stem, lead to instability and pain, did patient require revision surgery? false, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? all implants have been removed from pt.No implants were put back in place - girdlestone.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: no, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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 MBLOC HUM EPI 1 D8 STD
• 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: 10237682
• Report Number: 1818910-2020-15081
• Device Sequence Number: 14127544
• Product Code: HSD
• UDI-Device Identifier: 10603295027102
• UDI-Public: 10603295027102
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/24/2020

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: 130708100
• Device Catalogue Number: 130708100
• Device Lot Number: 5287779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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 D38MM; DXTEND MBLOC HUM EPI 1 D8 STD; DXTEND RETENT PE CUP D38 +6MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X36MM; METAGLENE +10MM; UNKNOWN SHOULDER HUMERAL STEMS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR