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

Catalog Number UNK SHOULDER METAGLENE

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); No Code Available (3191)

Event Date 06/08/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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.

Event Description

The literature article entitled ¿treatment strategies for infection after reverse shoulder arthroplasty¿ by reinhold ortmaier; herbert resch; wolfgang hitzl; michael mayer; ottokar studner; and mark tauber; published in eur j orthop surg tramatol online on june 8, 2013, was reviewed.The article¿s purpose was to report on a retrospective case series to describe specific treatment strategies for deep infection after reverse shoulder arthroplasty.During a 12-year period (between 1998-2010) 192 patients (192 shoulders ) were treated with either primary or revision rsa at the authors¿ institution.All procedures were performed by three experienced shoulder surgeons.The institution¿s shoulder database was searched for post-operative rsa infection.There were 21 shoulders in 21 patients treated for deep infection after rsa with a minimum follow-up time of 24 months.Of the 21 patients, one patient died from causes unrelated to the shoulder, which left 20 shoulders in 20 patients (95% follow-up rate).All 20 patients had interventions due to infection.Each patient is broken down with sex, age, treatment and complication (if any).Patient 18, (b)(6) year-old male, two-stage revision, inlay exchange (dislocation), hematoma.

• 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): 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: 9350949
• MDR Text Key: 185071763
• Report Number: 1818910-2019-115787
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER METAGLENE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/20/2019
• 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
• Patient Age: 79 YR