MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND GLENOSPHERE ECC D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number	130760042
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised due to loosening of the unknown component at bone to implant interface.Patient dislocated his reverse ltsa many months ago and never came back for surgery after being seen in clinic and was told to come back for surgery.Patient finally shows up in clinic over two years later and x-rays reveals that the metaglene, four screws and glenosphere had detached from the glenoid and was free floating in the shoulder.Removed and converted to a cta.Doi: (b)(6) 2019.Dor: (b)(6) 2021.Unknown shoulder side.
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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND GLENOSPHERE ECC D42MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12820439
• Report Number: 1818910-2021-25189
• Device Sequence Number: 14893148
• Product Code: HSD
• UDI-Device Identifier: 10603295027751
• UDI-Public: 10603295027751
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K120174
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 130760042
• Device Catalogue Number: 130760042
• Device Lot Number: 5327344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND GLENOSPHERE ECC D42MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; UNK SHOULDER HUMERAL CUP DELTA XTEND
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male