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

Catalog Number	140720101
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision shoulder delta motion post humeral fracture due to infection infection and loosening at the stem humeral.There was no surgical delay.
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 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 or Problem 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.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the revision shoulder delta motion post humeral fracture.Infection.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The x-ray investigation revealed that the global unite fx rsa epi 1 does not appear to have any separation/loosening from the bone, additionally, no damage to the implant was visible in the image.Therefore, the reported condition cannot be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the global unite fx rsa epi 1 would not contribute to the complained device issue.Based on the investigation findings,, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code 140720101, work order (b)(4) was manufactured on 13-june-2022.(b)(4) parts were manufactured per specification and all raw materials met specification.2 non-conformances associated with this lot were found, nr-0213954, nr-0212861.However, there is no correlation between these non-conformance and the failure mode of the complaint.

• Brand Name: GLOBAL UNITE FX RSA EPI 1
• Common Device Name: 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
• Report Number: 1818910-2024-07185
• Device Sequence Number: 8172449
• Product Code: PHX
• UDI-Device Identifier: 10603295444749
• UDI-Public: (01)10603295444749(17)320531(10)3815578
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 140720101
• Device Lot Number: 3815578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 07/19/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/18/2024; 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 90 KG