MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 52X18 STD; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number	1100-52-510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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
Patient had shoulder hemiarthroplasty performed in 2014, it has recently become unstable and required revision to total.Superior-posterior which required correction when reaming, also the proximal body was revised from 135deg to 142deg to help improve stability further.Doi: 2014.Dor: (b)(6) 2022.Unknown shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (nc search) was performed for the finished device 110052510, lot h37139 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: GLOBAL UNITE HEAD 52X18 STD
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16033376
• Report Number: 1818910-2022-25999
• Device Sequence Number: 5629816
• Product Code: HSD
• UDI-Device Identifier: 10603295004707
• UDI-Public: 10603295004707
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 12/22/2022

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 Model Number: 1100-52-510
• Device Catalogue Number: 110052510
• Device Lot Number: H37139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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: GLBL UNITE ANT BODY 135 SZ 14.; GLOBAL UNITE HEAD 52X18 STD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 121 KG