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

Catalog Number UNK SHOULDER HUMERAL EPIPHYSIS

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

Patient Problems Pulmonary Embolism (1498); Anemia (1706); Nerve Damage (1979); Loss of Range of Motion (2032); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

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

Article entitled ¿complications after surgical treatment of proximal humerus fractures in the elderlydan analysis of complication patterns and risk factors for reverse shoulder arthroplasty and angular-stable plating" written by alexander klug, md, dennis wincheringer, md, jasmin harth, ms, kay schmidt-horlohe, md, reinhard hoffmann, md, yves gramlich, md, published by the journal of shoulder and elbow surgery 2019 was reviewed.The current study was designed to evaluate which surgical procedure (angular-stable plating or rtsa) leads to lower complication and revision rates, and to determine possible independent risk factors in an elderly population.Between 2012 and 2017, 146 patients (aged 74.1 8.0 years) with complex phf were treated with locking plates (open reduction-internal fixation [orif]) or reverse total shoulder arthroplasty (rtsa).Complications and unplanned revision surgery were recorded in a mid-term follow-up.Potential patient and surgical risk factors for complications were extracted.Univariate and multivariate analyses were conducted.Follow-up data were available for 125 patients, 66 (52.8%) of whom were treated with locking plates, and 59 (41.2%) with rtsa.The overall complication rate was 37.8% for orif and 22.0% for rtsa, with a revision rate of 12.1% and 5.1%, respectively, as driven primarily by persistent motion deficits.Multivariate analyses demonstrated no significant differences between the 2.However, age was an independent protective factor against overall complications.Risk factors for major complications in orif included osteoporosis, varus impaction fractures, posteromedial metaphyseal extensions 4 mm, and multifragmentary greater tuberosities.For rtsa, higher complication rates were seen in patients with higher charlson indices, diabetes, or altered (greater) tuberosities.In contrast, neer¿s classification system was not predictive in either group.Depuy products: reverse shoulder prosthesis (delta xtend).Adverse events: motion deficits 9, instability 3, axillary nerve lesion 2, scapular notching 7, radiolucent lines (stem) 2, pulmonary embolism 2, postoperative anemia 1.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthese 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 device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
• Type of Device: SHOULDER HUMERAL EPIPHYSIS
• 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: 12488502
• MDR Text Key: 271925166
• Report Number: 1818910-2021-20406
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL EPIPHYSIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• 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