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

Model Number	130720102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/17/2021
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
Revision of delta xtend due to infection.Prosthesis removed and spacer used.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: h6 (clinical code).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the infections (e19).

• Brand Name: DXTEND MOD EPI 1 ECC LEFT 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: 11574983
• Report Number: 1818910-2021-06238
• Device Sequence Number: 4352599
• Product Code: HSD
• UDI-Device Identifier: 10603295027294
• UDI-Public: 10603295027294
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 130720102
• Device Catalogue Number: 130720102
• Device Lot Number: 5313074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND STAND PE CUP D42 +3MM; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND STAND PE CUP D42 +3MM; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR