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

Model Number 1100-48-610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Paresthesia (4421)

Event Date 09/03/2020

Event Type  Injury  

Event 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.

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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 305181532
• Report Number: 1818910-2022-24951
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004615
• UDI-Public: 10603295004615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 48; DEPUY/CMW 2G; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE STD STEM SZ 12
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 95 KG