MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND STAND PE CUP D38 +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738209

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 04/06/2023

Event Type  Injury  

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.

Event Description

It was reported that this was a rtsa for rotator cuff tear osteoarthrosis of left shoulder performed on (b)(6) 2022.On (b)(6) 2023, the patient fell off and the implant dislodged.Therefore, a revision surgery was performed.It was confirmed that the cup in question was worn out.A new similar implant was inserted, and the revision surgery was completed successfully.No further information is available.

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 which has not been investigated or verified 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.Added: b5, d10 and h6 (device code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 (clinical code).

Event Description

Additional information received: a.What was meant by "implant dislodged"? the implant dislocated from its original position due to the fall.B.Was there a surgery delay? if yes, what was the duration of the delay? no.

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 STAND PE CUP D38 +9MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16784934
• MDR Text Key: 313724183
• Report Number: 1818910-2023-08393
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027386
• UDI-Public: 10603295027386
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130738209
• Device Catalogue Number: 130738209
• Device Lot Number: 5378907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK SHOULDER GLENOSPHERE
• Patient Outcome(s): Required Intervention