MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW LOCK D4.5X48MM; DELTA XTEND IMPLANTS : SCREWS

Model Number	130790048
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Fall (1848); Inadequate Osseointegration (2646)
Date of Event	08/03/2020
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 shoulder prosthesis right side as patient suffered two falls before.There was loosening at the bone to implant interface.Doi: unknown, dor: (b)(6) 2020; right shoulder.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > examination of the returned device could not confirm the reported event.The device was manufactured on 23-february-2019.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot = > 1) quantity manufactured: 60 parts 2) date of manufacture: 23-feb-2019 3) any anomalies or deviations identified in dhr: no deviations or anomalies 4) expiry date: 31-jan-2024 5) ifu reference: w90930 h10 additional narrative: added: d4 (lot #) corrected: h3.

• Brand Name: DXTEND SCREW LOCK D4.5X48MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11239505
• Report Number: 1818910-2021-01951
• Device Sequence Number: 11623959
• Product Code: KWS
• UDI-Device Identifier: 10603295027874
• UDI-Public: 10603295027874
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 01/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 130790048
• Device Catalogue Number: 130790048
• Device Lot Number: 5337282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/09/2021
• 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 D38MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW LOCK D4.5X48MM; HYBRID HUM CUP EPI36 D38 +9MM; METAGLENE +10MM; UNKNOWN SHOULDER NON-LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR