MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE +10MM; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Model Number	1407-60-010
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	08/05/2020
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
Patient with delta xtend implants insitu, fractured scapula resulting in loose metaglene and glenosphere.Patient has rheumatoid arthritis and identified by the surgeon to have poor bone quality which he feels contributed to the implant failing.
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 related reported incidents against the provided product code/lot number combination 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.

• Brand Name: METAGLENE +10MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10410919
• Report Number: 1818910-2020-18194
• Device Sequence Number: 2552795
• Product Code: KWS
• UDI-Device Identifier: 10603295272908
• UDI-Public: 10603295272908
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K192448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/05/2020

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: 1407-60-010
• Device Catalogue Number: 140760010
• Device Lot Number: 5299595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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 D42MM; DXTEND HIGHMO PE CUP D42 +3MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR