MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 44X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110044610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that data use agreement was received which includes safety related data about survivorship worksheet 145 degree epiphysis and short stems.145 degree epiphysis subjects: subject #1: reporting a revision at day 29 of the delta xtend cup and glenosphere.Unknown reason for revision.Glenosphere lot: d20011257.Cup lot: 5382816.Subject #2: reporting a revision at day 397 of the delta xtend cup and glenosphere.Unknown reason for revision.Glenosphere lot: d19031580.Cup lot: 5376548.Subject #3: reporting a revision at day 95.Baseplate revision with iliac crest bone graft.Unknown reason for bone graft.Metaglene lot: 9724001.Non locking screw lot: 5378693.Locking screw lot: 5375467.Locking screw lot: 5379290.Subject #4: reporting a revision at day 251 of the delta xtend cup and glenosphere.Unknown reason for revision.Glenosphere lot: d19082641.Cup lot: 5372912.Short stem subjects: subject #1: reporting a revision at day 29 of the delta xtend cup and glenosphere.Unknown reason for revision.Glenosphere lot: d20011257.Cup lot: 5382816.Subject #2: reporting a revision at day 397 of the delta xtend cup and glenosphere.Unknown reason for revision.Glenosphere lot: d19031580.Cup lot: 5376548.Subject #3: reporting a revision at day 497 of the anatomic tsa due to infection.All components revised.Glenoid apg lot: jg4599.Humeral stem lot: d20121478.Anterior body lot: 9762278.Humeral head lot: jd0244.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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: GLOBAL UNITE HEAD 44X18 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21306922
• Report Number: 1818910-2025-02112
• Device Sequence Number: 21051877
• Product Code: HSD
• UDI-Device Identifier: 10603295004554
• UDI-Public: (01)10603295004554(17)20310331(10)JD0244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 110044610
• Device Lot Number: JD0244
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown