MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 52X21 STD; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110052520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6), study no: (b)(4).Clinical adverse event received for concern for glenoid component loosening/poly wear resulting in pain and dysfunction in right shoulder.Device and procedure (relatedness): device related: probable, procedure related: probable, date of event: 1 jan 2026, date of implant: (b)(6) 2013, date of revision: no information provided.Device location: right shoulder.Treatment/impact: aspiration: yes.Depuy synthes products used: catalog number: 113643026 lot number: 348444 component type: anchor description: premieron xlinked glenoid anchor peg 52mm.Catalog number: 113014000 lot number: 351106 component type: stem description: global humeral stem sz 14.Catalog number: 110052520 lot number: fk1jd1 component type: head description: global unite head 52x21 std.Catalog number: 113002000 lot number: 371961 component type: taper assembly description: global ap taper assembly 135 degree.
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.H11 additional narrative: a1: (b)(4).
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 perform.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.Added: d10 concomitant.

• Brand Name: GLOBAL UNITE HEAD 52X21 STD
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24743581
• Report Number: 1818910-2026-05525
• Device Sequence Number: 9377109
• Product Code: HSD
• UDI-Device Identifier: 10603295004714
• UDI-Public: (01)10603295004714(17)210301(10)FK1JD1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• 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 Expiration Date: 03/01/2021
• Device Catalogue Number: 110052520
• Device Lot Number: FK1JD1
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CROSSLINK ANCHOR PG GLENOID 52; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL STEM 14MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male