MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER METAGLENE

Catalog Number UNK SHOULDER METAGLENE

Device Problem Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/31/2020

Event Type  Injury  

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.

Event Description

An article, entitled: ¿is bone grafting always necessary in revision reverse total shoulder arthroplasty with uncontained glenoid bone defects?¿, by lotte verstuyft, md, laurence vergison, md, alexander van tongel, md, phd, lieven de wilde, md, phd, and published in j shoulder elbow surg (2021) 30, 1891¿1898, was reviewed.The study evaluated revision surgery of both anatomic total shoulder arthroplasties and reverse shoulder arthroplasties where the patients presented with uncontained glenoid boney defects.These were defined as those bone defects that were not superior or centrally contained in the native glenoid bone boundaries, instead running beside or crossing over the perimeters of those boundaries.This scenario complicates fixation of the revision metaglene baseplate, as the central fixation peg can ¿blow-out¿ the remaining glenoid bone and fail.Bone grafting to attempt to restore the native glenoid plane has been the standard approach to address this complex scenario.The authors present an alternative approach not requiring the grafting, but rather an alternative implant re-orientation and fixation technique.Sixty patients were included in the study.The authors did not include information identifying manufacturers for the components initially revised.For purposes of treatment, depuy delta xtend shoulders were implanted, and patients either received bone grafting (iliac crest autograft, or femoral head allograft) to restore the premorbid glenoid plane, or the authors¿ technique, central peg positioning in the spine pillar (cppsp) of the native scapular spine.The following complications were reported: complication: cppsp, bone graft.Clavicle fracture: 2, 2.Nonunion of clavicle:1, 0.Scapular notching: 0, 2.Hematoma: 0, 1.Metaglene loosening: 0, 3.Glenoid graft resorption: 0, 1.Dislocation - instability: 3, 0.Periprosthetic fracture - humerus: 1, 1.Stress fracture around scapula: 2, 1.The primary failures in each group were shoulder dislocation for cppsp (treated with revision glenosphere and humeral cup), and metaglene implant loosening in the bone graft group (treated with glenoid construct revision and additional bone grafting).Non-union and clavicle fractures were related to clavicle osteotomies used in the surgical approach for exposure of the glenoid (treated conservatively).Humerus fractures were treated with revision to long humeral stem, or plate osteosynthesis.Stress fractures around the scapula were treated conservatively with braces and no surgery.Results demonstrated better functional outcomes for the cppsp group over the bone graft group, primarily in the area of post-operative strength.Other indicators were similar.The authors found that their technique was a successful means to treat uncontained glenoid defects in shoulder revision surgery, and offered some advantages over traditional bone grafting techniques.Patients in study were not identified by specific case or age/gender identifiers.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination.No lot code provided.All available radiographs were reviewed and no evidence of implant fracture, disassociation or anything indicative of a device non-conformance was found.Allegation could not be confirmed.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 : no evidence or deficiency suspecting an error in manufacturing/material that would be a contributing factor in the reported allegation(s) was identified.A device history record (dhr) review or manufacturing records evaluation (mre) was not necessary (nor possible without the lot code).

• Brand Name: UNKNOWN SHOULDER METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 12421220
• MDR Text Key: 270842522
• Report Number: 1818910-2021-19281
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• 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 METAGLENE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• 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