MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE FX RSA EPI 1; SHOULDER HUMERAL STEM ACCESSORY

Catalog Number 140720101

Device Problem Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

Revision shoulder delta motion post humeral fracture due to infection infection and loosening at the stem humeral.There was no surgical delay.

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.H10 additional narrative: added: b5 and d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received: a.What is the event date? (b)(6) 2024 b.What is the explant date (mm/dd/yyyy)? (b)(6) 2024 c.Can you provide the scheduled date of revision surgery? (b)(6) 2024 d.It was indicated that there was loosening.On what interface did the loosening occur? stem humeral e.Please confirm the manufacturer of the cement product.Is it depuy manufactured? if yes, please provide the product code and lot number of the cement product.Stryker simplex f.Can you provide the quantity used for the cement product? 1 g.Was there any surgical delay related to the event? if yes, what is the duration of the delay? no h.Is the biostop g, träger an instrument utilized to insert a cement restrictor, a cement restrictor trial, or the definitive cement restrictor? definitively implant.I.Is size 8 correct? can you describe what was meant by, "left behind in previous surgery"? 8 j.Was the previous surgery the primary implantation or a revision procedure? primary post fracture.K.Why was the device left behind? the surgeon unscrewed the introducer tip disengaging tip instead of pulling it out.¿ was it supposed to be taken out? ¿ was it still inside the patient? ¿ if inside, will there be a procedure for removal? ¿ what was the surgeon¿s opinion- is it safe to leave inside / any chance of migration? "the tip remains in the patient, we tried to remove it but couldn't.To retrieve it we would have meant we had to open the bone involving a bigger operation.The surgeon isn't concerned that it's remained in the bone and shouldn't move.The original surgeon unscrewed the tip as most surgeons are used to unscrewing cement restrictors from the introducer.Biostop has an introducing tip and the implants slide over the tip.He pushes the implant down and then pulls back on the introducer leaving the implant behind.".

• Brand Name: GLOBAL UNITE FX RSA EPI 1
• Type of Device: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19018684
• MDR Text Key: 339097413
• Report Number: 1818910-2024-07185
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295444749
• UDI-Public: 10603295444749
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170748
• 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
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 140720101
• Device Lot Number: 3815578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BIOSTOP G CEM RESTR 8MM; DXTEND GLENOSPHERE STD D42MM; DXTEND GLENOSPHERE STD D42MM; GLOBAL UNITE STD STEM SZ 6; UNK SHOULDER HUMERAL CUP DELTA XTEND
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 90 KG