MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	130720101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/09/2020
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
It was reported that this was an rtsa (reverse total shoulder arthroplasty) treating cuff tear arthroplasty on (b)(6) 2020.When the modular centered epiphysis was inserted into the humerus, the inner cortical bone cracked.The surgeon corrected the stem and reinserted the implant, but the greater tubercle cracked.He left the implant deployed in the humerus, tied up the cracked bones, and completed the procedure less than 30-minute surgical delay.The patient is currently hospitalized, and she is not scheduled to undergo a revision procedure.The surgeon commented as follows: he performed the procedure as per surgical instruction.He evaluated this event as severe.He usually uses other suppliers¿ devices but has not experienced such a case before.The bone size and fragility might have triggered the event.The patient¿s medical history, treatment history, and comorbidity had nothing noticeable.She does not have an allergy or smoke.The device was brand new and the first use when the issue occurred.
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.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND MOD CENT EPI 1 HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10885326
• Report Number: 1818910-2020-25216
• Device Sequence Number: 1154145
• Product Code: KWS
• UDI-Device Identifier: 10603295027287
• UDI-Public: 10603295027287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: MM 49-12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2020

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: 130720101
• Device Catalogue Number: 130720101
• Device Lot Number: 5361398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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: UNK SHOULDER HUMERAL STEM DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR