MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL CUP

Catalog Number UNK SHOULDER HUMERAL CUP

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); No Code Available (3191)

Event Date 08/27/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device was received.Root cause undetermined.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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

In the article entitled ¿revision of reversed total shoulder arthroplasty.Indications and outcome.¿ written by mazda farshad; marion grogli; sabrina catanzaro; and christian gerber; was reviewed.The articles purpose was a retrospective study to identify the reasons for revision of reverse total shoulder arthroplasty (rtsa) and to report outcomes.The article was based on rtsa¿s performed with implants of the: delta iii (depuy) 232 implanted, and a competitor, 248 implanted between 1999-2008.67 cases needed at least one additional intervention to treat a complication, 30 of them needed a second, eleven of them a third and four a fourth additional intervention.The most common complication requiring a first intervention was instability, followed by a hematoma or superficial wound complications and complications of the glenoid component.Patients benefited from the rtsa despite the need of additional interventions as indicated by a mean increase in total constant-murley score from 23 points before rtsa to 46 points at final follow-up.Complications were as follows--all of which required revisions: instability resulting in subluxations or dislocation.Five were closed reductions, seven required a change of components to a selection of a higher humeral polyethylene inlay was used in three, revision of glenoid component in two, and revision of a humeral component in two cases.Eight resulted in hematomas with simple evacuation.Three complications of glenoid component-one changed glenoid conversion and two component wear.One for pain.Two deficient in external rotation.Three for infection.Three for humeral component loosening.Two disturbing orif material.Two periprosthetic fractures.One dislocation of greater tuberosity.One heterotopic ossification.

• Brand Name: UNKNOWN SHOULDER HUMERAL CUP
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9281429
• MDR Text Key: 179520086
• Report Number: 1818910-2019-114201
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• 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