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 Codes	Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Date of Event	06/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Left shoulder replacement revision for dislocation - surgeon noted that in primary shoulder (completed by him (b)(6) 2022) the metaglene has been positioned quite high on the face of the glenoid, causing the humeral cup to notch on the inferior neck of glenoid.Surgeon removed glenosphere and humeral cup, removed extra bone from neck of glenoid and replaced the glenosphere as well as adding a retentive cup doi: (b)(6) 2022.Dor: (b)(6) 2022.Left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: device associated with this report was not received for examination.All available x-rays and photographs were reviewed.A complaint is confirmed, a dislocation event can be observed.However, no product defects that could have contributed to the reported event were identified.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: 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the metaglene was mispositioned.No delay reported.

• 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 anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14773036
• Report Number: 1818910-2022-11406
• Device Sequence Number: 1294215
• Product Code: HSD
• UDI-Device Identifier: 10603295027751
• UDI-Public: 10603295027751
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2022

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: 5389754
• 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: 06/04/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 08/30/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/29/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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 STAND PE CUP D42 +6MM; DXTEND STAND PE CUP D42 +6MM; METAGLENE; UNKNOWN SHOULDER METAGLENE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown