MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 44X15 STD; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number	1100-44-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient underwent the primary procedure (artificial bone head insertion) for treating proximal humeral fracture.It became obvious that the range of motion had become more restricted as time passed.On (b)(6) 2021, an rsa was performed to replace the devices in question with delta extend system to secure the range of motion.The stem (unk) was reused.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 (mre) was not possible because the required lot code was not provided.

• Brand Name: GLOBAL UNITE HEAD 44X15 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: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13042772
• Report Number: 1818910-2021-28394
• Device Sequence Number: 5424317
• Product Code: HSD
• UDI-Device Identifier: 10603295004516
• UDI-Public: 10603295004516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,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 Model Number: 1100-44-500
• Device Catalogue Number: 110044500
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: GLOBAL UNITE BODY SZ 10 -5; GLOBAL UNITE COLLAR SZ 44
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female