MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 48X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number	1100-48-610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Paresthesia (4421)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for pain in shoulder region after shoulder replacement; chronic pain.Event is not serious and is considered mild.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2020.Date of event: (b)(6) 2020.(right shoulder).Treatment: initial work up for infection with blood work.
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.
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.H10 additional narrative: 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
Patient underwent a successful anatomic shoulder arthroplasty on (b)(6) 2020.Post-operative clinic visit on (b)(6) 2020 states she is having brachial plexopathy symptoms along the c6 dermatome (pain and decreased sensation to be captured as nerve injury).On (b)(6) 2021, the patient continues to have strength and range of motion limitations requiring more physical therapy.She has lateral shoulder pain over the lateral acromion/subacromial space.Xray review shows some ¿minor stress shield related resorption of medial humeral calcar when compared to previous xrays¿.Clinic visit on (b)(6) 2022 states she has ongoing pain and in 4 weeks will have blood drawn to check crp, esr and wbc for potential infection as the source of her pain.The numbness and tingling on the radial aspect of the right forearm and tip of the thumb is still present and likely to not improve.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: GLOBAL UNITE HEAD 48X18 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15951432
• Report Number: 1818910-2022-24951
• Device Sequence Number: 6419285
• Product Code: HSD
• UDI-Device Identifier: 10603295004615
• UDI-Public: 10603295004615
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 12/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1100-48-610
• Device Catalogue Number: 110048610
• Device Lot Number: J66W89
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 01/20/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/14/2022; 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• 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 48; DEPUY/CMW 2G; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE STD STEM SZ 12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 95 KG