MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE STD STEM SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	110010100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the global unite stem would not mate with the epi proximal body.There was a space in between the two implants.Another stem was opened and it mated perfectly with the proximal implant.If other, describe total shoulder.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed little marks inside the circular surface of the global unite std stem sz 10, indicative of the device being tried to implant.A manufacturing record evaluation was performed for the finished device 4554806 lot number, and no non-conformances nor manufacturing irregularities were identified.A dimensional inspection was performed for the global unite std stem sz 10 and met specifications.A functional evaluation was not performed as the mating component was not returned for evaluation.The overall complaint was not confirmed as the observed condition of the global unite std stem sz 10 would have not contributed 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 j&j medtech orthopaedics 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.Drawing/specifications reviewed: dwg-110010100 rev b.Current.Dimensional inspection: specified dimensions device length = 113.15 ± 1.00 mm, length from the bottom of the threaded hole to the surface = 18.50 ± 1.00 mm, length from the bottom of the non-threaded hole to the surface = 9.00 ± 0.20 mm.Measured dimensions: device length = 113.53 mm (complies), threaded hole length to the surface = 18.69 mm (complies), 2nd hole length to the surface = 8.92 mm (complies).Device used: digimatic caliper cd78621.Device history lot a manufacturing record evaluation was performed for the finished device 4554806 lot number, and no non-conformances nor manufacturing irregularities were identified.Device history review a manufacturing record evaluation was performed for the finished device 4554806 lot number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: corrected: h3.
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported, that during a total shoulder procedure.The global unite stem would not mate with the epi proximal body.There was a space in between the two implants.Another stem was opened and it mated perfectly with the proximal implant.There was a 5 minutes of surgical delay.The procedure was successfully completed.
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.H11 additional narrative: added: d6b, d9, h4.Corrected: d4 (lot, expiry date, primary udi number).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the global unite stem would not mate with the epi proximal body.There was a space in between the two implants.Another stem was opened and it mated perfectly with the proximal implant.The product was returned to j&j medtech orthopaedics for evaluation.Additionally, a manufacturing investigation was raised for the complaint issue.Visual inspection revealed minor marks on the circular surface of the global unite std stem sz 10, suggesting that the device may have been previously attempted for implantation.Additionally, the tab appears to exceed the acceptable tolerance range.Based on the manufacturing investigation, it was confirmed that the tab width was outside the maximum tolerance, the assignable cause was caused by a manufacturing issue due to ¿man¿ and ¿machine¿.This complaint was attributed to the damaged tool within the cnc mill machine and human error as the shadowgraph inspection was missed.The overall complaint was confirmed as the observed condition of the global unite std stem sz 10 would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance" activities.Device history lot: a manufacturing record evaluation was performed for the finished device 4554806 lot number, and no non-conformances nor manufacturing irregularities were identified.However, an nc was raised to address the reported issue.Device history review: a manufacturing record evaluation was performed for the finished device 4554806 lot number, and no non-conformances nor manufacturing irregularities were identified.However, an nc was raised to address the reported issue.Corrected: h3.

• Brand Name: GLOBAL UNITE STD STEM SZ 10
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20868518
• Report Number: 1818910-2024-25033
• Device Sequence Number: 8622267
• Product Code: HSD
• UDI-Device Identifier: 10603295004080
• UDI-Public: (01)10603295004080(17)340731(10)4554806
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110010100
• Device Lot Number: 4554806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 01/22/2025; 10/06/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/13/2025; 01/23/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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
• Patient Sex: Female