MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DXTEND GLENOSPHERE STD D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number 130760138

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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 a revision case that occurred today at (b)(6) hospital (b)(6) 2023).This is the same 82 year old female patient and same joint that was revised last tuesday (b)(6)2023) and reported (b)(4).The patient had to be re revised today as the right shoulder had dislocated.The surgeon removed the 38 +9mm standard pe cup which he had inserted last week (b)(6) 2023).He also removed the glenosphere size 38mm ref 1307-60-138, lot 5318366 exp 05/2023 which was inserted at the primary surgery 5 years ago.Today (b)(6) 2023) he inserted a +9mm spacer and a 42+6 pe standard cup with a 42mm standard gelnosphere and was happy with the outcome.Implants retained by the hospital.

• Brand Name: DXTEND GLENOSPHERE STD D38MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• 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: 16741935
• MDR Text Key: 313297414
• Report Number: 1818910-2023-07936
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 130760138
• Device Catalogue Number: 130760138
• Device Lot Number: 5318366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DXTEND GLENOSPHERE STD D38MM.; DXTEND STAND PE CUP D38 +9MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female