MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP DELTA XTEND

Catalog Number UNK SHOULDER HUMERAL CUP DELTA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Post Operative Wound Infection (2446); Fluid Discharge (2686); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled "reverse shoulder arthroplasty in rheumatoid arthritis: survival and outcomes¿ written by christophe levigne, md, mika¿el chelli, md, tyler r.Johnston, md, marie-charlotte trojani, md, daniel mole, md, gilles walch, md,pascal boileau, md; published by journal of shoulder and elbow surgery published online 2021 was reviewed.The article's purpose was to ¿report prosthesis survival, complications, and outcomes of rsa in patients with rheumatoid arthritis (ra) at minimum 5-year follow-up.¿ patient data: age at surgery: 70 +- 9; female: 89%; prior rotator cuff surgery: 8%.Medical history: rotator cuff tear, rheumatoid arthritis delta reverse prosthesis (depuy orthopedics, (b)(6)) in 15% of the cases and competitor aequalis reverse prosthesis in 85%.A 29-mm baseplate was typically implanted flush with the inferior glenoid margin to be as low as possible and fixed with 4 screws.The diameter of the glenosphere was 36 mm in 97% of the cases, and all but 1 humeral stems were cemented ¿ cement manufacturer not provided.Depuy products: delta reverse shoulder system.Adverse events: pain.Infection.Instability.Glenoid disassembly.Dislocation.Metaglene screw loosening.Temporary axillary nerve palsy.Temporary ulnar nerve palsy.Wound drainage and infection.Marginal glenoid fracture ¿ no intervention.Avulsion fracture of the coracoid - treated intraoperatively with osteosutures greater tuberosity fracture - treated intraoperatively with osteosutures.Incomplete screw fixation of the glenosphere on the baseplate intraoperatively.Closed reduction.Irrigation and debridement.Device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Reviewing the x-rays on the article, no evidence have been found of an implant fracture, disassociation oy anything indicative of a device non-conformance.There is no evidence to confirm any loosening.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.Updated: h6 (clinical code) unspecified infection (e1906) to capture infection.

• Brand Name: UNK SHOULDER HUMERAL CUP DELTA XTEND
• Type of Device: SHOULDER HUMERAL CUP
• 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 ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12421036
• MDR Text Key: 271674972
• Report Number: 1818910-2021-19273
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL CUP DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention